QUALITY CONTROL ANALYST JOB DESCRIPTION

Every batch released to patients or clinical trials has passed through this function. The Quality Control Analyst owns laboratory testing, data review, and deviation investigation for in-process, release, and stability samples in regulated pharmaceutical and biopharmaceutical manufacturing. This is not a passive checkpoint role. Holding this position means making documented, defensible decisions under cGMP, ICH guidelines, and FDA oversight - decisions that determine whether a drug product moves forward or stops.

As the Quality Control Analyst, you ensure that analytical test results for Drug Substance, Drug Product, and raw materials meet regulatory specifications and internal quality standards, supporting compliant product release in a GMP-regulated manufacturing environment. You work within the QC laboratory organization, collaborating with Regulatory Affairs, Manufacturing, and Quality Assurance teams while reporting to QC laboratory management.

Career Impact: Hands-on experience with release and stability decisions under FDA and ICH regulatory frameworks builds the kind of documented, auditable expertise that advances careers toward Senior Analyst, QC Specialist, or method validation leadership.

Business Impact: When test results are accurate and investigations are closed on time, manufacturing schedules hold and clinical programs advance without regulatory delay - outcomes that depend directly on this role's day-to-day execution.

Growth Opportunity: Exposure to method qualification, CAPA authorship, and Health Authority inspection support expands the scope available to analysts who move into QC management, regulatory submissions, or external CMO oversight roles.

• Perform analytical testing of in-process, release, and stability samples to support compliant drug substance and drug product release decisions.
• Review and verify laboratory data for accuracy, completeness, and compliance with cGMP documentation standards.
• Author and close deviation reports, CAPAs, and Change Controls within established timelines to maintain inspection readiness.
• Validate and qualify analytical test methods, including participation in method transfers from development or external laboratories.
• Monitor environmental and utility systems, including clean room viable and non-viable sampling, to maintain facility compliance standards.
• Maintain laboratory equipment through scheduled calibration, preventive maintenance, and timely documentation of equipment status.
• Support internal audits and Health Authority inspections by preparing data, responding to observations, and implementing corrective actions.
• Train and guide junior QC Analysts on test methods, GMP documentation practices, and laboratory safety procedures.

• Bachelor's degree in Chemistry, Biochemistry, Microbiology, Biological Sciences, or a related life science field, or equivalent work experience.
• 3 or more years of analytical testing experience in a GMP-regulated pharmaceutical or biopharmaceutical laboratory environment.
• Working knowledge of cGMP regulations, ICH guidelines, and FDA documentation requirements applicable to QC laboratory operations.
• Demonstrated ability to author and review deviation reports, CAPAs, and SOPs in a regulated quality management system.
• Proficiency in laboratory data review including trend analysis, out-of-specification investigations, and compendial test interpretation.
• Familiarity with chromatographic and spectroscopic testing techniques applicable to raw material, in-process, and finished product analysis.
• Strong written and verbal communication skills with the ability to present technical findings clearly to cross-functional stakeholders.
• Ability to manage multiple concurrent assignments under GMP conditions with high attention to documentation accuracy.

• Experience with plate-based bioassays such as ELISA, cytotoxicity assays, or cell signaling methods in a GMP testing environment.
• Prior exposure to environmental monitoring programs including clean room sampling, bioburden testing, and utility system analysis.
• Knowledge of compendial standards from USP, EP, or JP and their application to in-process and release testing specifications.
• Experience working with Contract Manufacturing Organizations on data verification, method enhancement, or stability program oversight.

• Batch release cycle time, measuring how consistently testing is completed within the scheduled manufacturing window.
• Deviation closure rate within target days, reflecting timely investigation and documentation of laboratory nonconformances.
• Audit observation count per inspection cycle, tracking the laboratory's readiness and documentation compliance posture.
• Out-of-specification rate per product family, measuring the frequency and pattern of test results requiring formal investigation.
• CAPA effectiveness score, indicating whether corrective actions prevented recurrence of identified quality failures.
• Typical tools: laboratory information management systems (commonly LIMS platforms); chromatography data systems (commonly Empower or Chromeleon)

• Base Salary Range: $60,000 to $95,000 per year, depending on seniority and location.
• Bonus: Annual performance bonus, typically 5 to 10 percent of base salary.
• Equity: Not standard at this level; offered selectively at larger biotech employers.
• Health Benefits: Medical, dental, and vision coverage; employer-sponsored plans standard across the industry.
• PTO: 15 to 20 days annually, plus company-observed holidays and potential sick leave bank.
• Common Perks: Laboratory safety training, tuition reimbursement, shift differentials for non-standard hours, professional certification support.

Figures are estimates based on general US market benchmarks and may be outdated. Adjust based on location, company size, and seniority level.

Qualified applicants are considered for employment without regard to race, color, religion, sex, national origin, age, disability, veteran status, genetic information, sexual orientation, gender identity, or any other characteristic protected under applicable federal, state, or local law. Background screening, which may include drug testing consistent with pharmaceutical manufacturing standards, is a condition of employment. Reasonable accommodations for applicants with disabilities are available upon request throughout the hiring process. Candidates must be authorized to work in the United States.

The Quality Control Analyst owns analytical testing for release, stability, and in-process samples across raw materials, intermediates, and finished products in a cGMP-regulated environment. Working alongside compliance and laboratory teams, this role shapes product quality outcomes by driving HPLC-based testing, Discrepancy Management investigations, and SOP development that directly support commercial manufacturing releases.

Key Responsibilities

• Perform analytical testing to support the release, stability, and in-process testing of samples, final products, and materials for production or commercial use.
• Follow relevant SOPs and perform all activities in accordance with cGMP requirements, reporting abnormalities.
• Initiate and complete laboratory discrepancy events on time.
• Document test results to ensure completeness and accuracy per cGMPs.
• Demonstrate hands-on knowledge of operating, maintaining, and troubleshooting HPLC instruments and related quality and regulatory requirements.
• Perform moderate to complex equipment troubleshooting and laboratory cleaning activities.
• Contribute to the development, revision, validation, and review of quality systems, SOPs, and methods for raw materials, intermediates, or finished products.
• Support improvement projects related to release goals, root cause identification, and laboratory test method improvements.
• Perform Discrepancy Management investigations, write and review laboratory investigation reports, and implement corrective and preventative actions.
• Perform assay training, manage multiple tasks concurrently, and assist with assay troubleshooting.

Required Qualifications

• Bachelor's degree in Biological Sciences, Biochemistry, Chemistry, Molecular Biology, or a related field.
• 5+ years of experience in a cGMP compliant environment with thorough understanding of manufacturing process records.
• Experience with a cGMP and global regulatory compliance organization.
• Solid background in protein, carbohydrate, small molecule, and excipient testing using chromatography techniques.
• Experience with wet-chemical techniques and spectroscopy, and knowledgeable with LIMS and SAP systems.
• Experience with chromatography systems and software including Waters/Empower, Dionex/Chromelean, Agilent/Chemstation, and AKTA/Unicorn.
• Strong computer, communication, and technical writing skills for reports and SOPs, with familiarity with JMP.

Embedded within the Quality organization, the Quality Control Analyst executes Post-Market Surveillance activities including Complaint Assessment, Reportability Determination, and Final Complaint Review to ensure product and regulatory compliance. Working closely with Consumer Services, regulatory bodies, and manufacturing teams, this role advances complaint resolution and continuous improvement outcomes across assigned product lines.

Core Functions

• Execute assigned Post-Market Surveillance activities including Complaint Assessment, Reportability Determination, and Final Complaint Review for low severity complaints.
• Complete Low Level Complaint Investigation records and provide Post-Market Surveillance support for assigned mills and products.
• Maintain relationships with Consumer Services, including reporting and troubleshooting errors and coordinating complaint handling activities.
• Ensure activities and items are compliant with QMS, ISO, FDA GMP standards, and applicable government regulations.
• Execute continuous improvement plans and activities for established processes as assigned.
• Conduct all communications and transactions with integrity and escalate issues as they occur.
• Assist with Quality Checks and complete all required training within required timeframes.

Qualifications and Experience

• Bachelor's degree in science, engineering, or a related discipline, and/or 1+ years of experience in Quality, Manufacturing, Research and Engineering, or a Regulatory function.
• 1-3 years of customer service or complaint handling experience preferred, with ETQ experience and knowledge of FDA and Health Canada regulations highly desired.
• Knowledge of Medical Device, Consumer, Cosmetic, and/or Drug regulatory requirements desired.
• Demonstrated application of LEAN and Continuous Improvement skills.
• Basic computer and software skills with proficiency in Microsoft Office tools.
• Strong interpersonal, oral, and written communication skills with attention to detail and ability to multitask in a fast-paced environment.

Reporting to the Manager, the Quality Control Analyst reviews loan documentation and approves transactions across multiple Deal Set-up teams and Lines of Business on applicable commercial loan systems. Partnering with processing teams under daily deadlines, this role ensures downstream accuracy and compliance in commercial loan bookings, fundings, and modifications that support the integrity of high-volume financial operations.

Primary Duties

• Review documentation to ensure compliance with credit, audit, and funding requirements, and verify that approved documents are consistent with executed documents.
• Perform Quality Review and Approval of new loan bookings, renewals, modifications, fundings, wires, payments, and rate updates on commercial loan systems.
• Ensure processed work is in compliance with procedures using multiple loan and supporting systems.
• Communicate and clarify information regarding submitted items with processing teams.
• Meet service level expectations in addition to team and individual goals.
• Participate in projects as assigned by the Manager.

Skills and Qualifications

• A college degree or 2-3 years of financial services or operations experience required, with prior experience in Quality and Control, Commercial Loan Booking and Funding, or Loan Processing preferred.
• Successful completion of all periodic High Value Business Entitlements background checks required.
• Strong analytical, problem solving, and judgment skills with excellent verbal and written communication skills.
• Proficient in all MS Office programs with the ability to navigate multiple applications and quickly adopt new systems.
• Ability to organize, prioritize, and handle multiple tasks concurrently in a metrics-driven environment with tight service levels.
• Strong work ethic, sense of urgency, and ability to function cooperatively in a team environment while sharing information and supporting department plans.

Sitting at the intersection of quality assurance and laboratory science, the Quality Control Analyst supports Chemistry and Microbiology laboratories by conducting biochemical, microbiological, and general chemical testing of raw materials, in-process, and final product samples in a GMP-regulated setting. Operating across testing, documentation, and audit-readiness functions, this role enables compliant product release and continuous improvement by maintaining laboratory systems, training personnel, and executing CAPAs within an established quality framework.

Duties

• Perform peer review of laboratory data and maintain laboratory housekeeping including sample management, reagent prep, and instrument standardization and calibration.
• Use electronic systems for execution and documentation of testing.
• Complete document revisions and maintain individual training in a compliant state, including training new laboratory personnel.
• Complete CAPAs when required and participate in continuous improvement initiatives.
• Maintain the laboratory in an audit-ready state and participate in internal and Health Authority inspections.
• Provide input to functional laboratory meetings.

Experience and Qualifications

• Bachelor's degree in a life science required, with a minimum of 1 year of proven experience preferred.
• Experience with basic laboratory skills and some knowledge of analytical methodologies including spectroscopy, bioburden, endotoxin, and pH testing.
• Knowledge and understanding of cGMP requirements related to the QC laboratory, with ability to identify gaps in processes or systems.
• Knowledge of compendial requirements such as USP, EP, and JP preferred, and detailed knowledge of statistical concepts applied to laboratory data preferred.
• Proficient with Microsoft Office applications including Outlook, Excel, Word, and PowerPoint.
• Electronic systems including LIMS, MES, LES, Empower, and Trackwise used for testing execution and documentation.

A key member of the Fidelity Medicare Sales and Service support team, the Quality Control Analyst reviews associate and client interactions with a focus on call quality, policy adherence, and process improvement. Collaborating across Medicare Sales Leadership, Compliance, and new hire training programs, this role helps reduce operational risk and improve the customer experience by analyzing call quality data, conducting root cause analysis, and facilitating training sessions for Sales Agents.

Accountabilities

• Analyze call quality data to identify gaps in current processes and opportunities to improve the customer experience.
• Record observational data and present results and recommendations to senior management and compliance.
• Identify new control processes to reduce risk in the operating environment and conduct proactive root cause analysis of data quality trends.
• Facilitate training sessions for Sales Agent new hire classes and assist with documenting and updating procedures in the business unit knowledge repository.
• Participate in feedback and coaching sessions as needed and manage workload in an Agile environment.
• Collaborate with Medicare Sales Leadership and Compliance on a regular basis to calibrate calls and review trends.

Requirements

• Bachelor's degree or equivalent experience, with a minimum of 2 years of call center experience.
• Knowledge of health insurance and/or Medicare products, with experience in auditing and/or quality control processes.
• Ability to analyze data sets to identify trends and challenges, with strong critical thinking and independent decision-making skills.
• Proficient in Microsoft Office tools including Excel, PowerPoint, and SharePoint.
• Experience with NICE, Salesforce, and MyGPS preferred.
• Excellent communication skills to operate effectively across multiple teams, with a proven ability to work both autonomously and collaboratively.
• Extremely detail-oriented, self-motivated, and able to quickly adapt to change while taking initiative to design improved processes and controls.

Sustained product quality in clinical and commercial biopharmaceutical programs depends on the Quality Control Analyst III, who performs and reviews routine and non-routine plate-based assays including cytotoxicity bioassay, AlphaLISA, and Binding ELISA in a GMP testing environment. Based within the QC organization and serving as SME for test methods, this role delivers compliant release and stability testing outcomes that directly enable clinical development and commercial program success.

Key Deliverables

• Perform routine and non-routine plate-based assays such as cytotoxicity bioassay, AlphaLISA, Binding ELISA, and Cell Signaling Bioassay with advanced proficiency.
• Author and own deviations, CAPAs, and Change Controls, and revise and/or author standard operating procedures.
• Participate in qualification and validation of test methods and serve as SME for test methods or other areas of expertise.
• Work closely within the QC organization and on cross-functional teams to ensure successful completion of group objectives.
• Use LIMS to support the QC testing group and apply GMP principles on a daily basis.
• Identify and participate in continuous improvement projects and troubleshooting and laboratory investigations.

Technical Qualifications

• BS/BA or AA with 2+ years in a relevant field, plus 6+ years of experience in the pharmaceutical or biopharmaceutical industry.
• 3+ years of experience working in a GMP laboratory with strong technical skills and in-depth understanding of plate-based assays and cell culture.
• Experience in GMP data review, with strong knowledge of GMP compliance and experience authoring or revising standard operating procedures.
• Strong technical writing, communication, data interpretation, and troubleshooting skills.
• Proficient with Microsoft Office applications including Word, Excel, Outlook, and SharePoint.
• Highly organized with strong attention to detail and ability to manage complex laboratory tasks independently.

As the Quality Control Analyst, this role supports hedge fund underwriting quality by attending client due diligence meetings, challenging credit officer work, and developing control processes around key data inputs in Credit Approval documentation packages. The Credit team relies on this work to maintain accuracy in counterparty risk ratings, scorecard inputs, and downstream aggregation processes that protect the firm's credit extension decisions.

Job Functions

• Attend client due diligence meetings and help credit officers document feedback.
• Challenge the quality and accuracy of work done by credit officers to ensure memos and scorecards are completed properly.
• Review counterparty details in CitiRisk to ensure accuracy of key data fields used for risk tagging and aggregation.
• Create, enhance, and document processes to evidence a robust control environment.
• Work on projects to enhance team productivity and automation of analytical tools.
• Assess the quality of risk underwriting decisions and drive adherence to policy with sound judgment.

Position Requirements

• 2-5 years of relevant job experience with a basic understanding of capital markets products and trading strategies.
• Experience in creating control processes and procedures, with strong attention to detail.
• Excellent analytical ability with interest in developing hedge fund industry knowledge.
• Strong written and verbal communication skills.
• Willingness to synthesize client risk information and challenge senior credit officers.

Quality Control Analyst controls the accuracy and compliance of Business Services monetary and administrative files and transactions across internal computer systems. Success in the position means client files are analyzed, corrective measures are applied, reconciliation controls are executed, and audit requirements are met so that the Business Services team can operate in full alignment with banking policies and applicable legislation.

Areas of Ownership

• Create, analyze, control, and document client files in different computer systems.
• Prepare, analyze, and control documents related to products and client files.
• Recommend and apply corrective measures to make files compliant and ensure follow-up.
• Complete and update control reports and carry out efficient controls for reconciliation of monetary and administrative transactions.
• Cooperate in audits, provide requested information, and apply required corrective measures.
• Participate in implementing and updating procedures, and support the Business Services teams in solving problems.
• Perform all work in compliance with specific practices, policies, and objectives, and keep knowledge up to date.

Background and Experience

• Bachelor's degree in business administration or a related field.
• 1-3 years of experience in data analysis, with experience in banking an asset.
• Strong proficiency in using different computer systems and knowledge of specialized data analysis tools.
• Excellent written and verbal communication skills with strong thoroughness, team spirit, and collaboration.
• Autonomous with a strong sense of initiative.

The Quality Control Analyst produces regulatory-ready client profile reviews by examining LifeCycle consistency across legal and commercial documents, executing AML policies, and preparing metrics for regulatory reporting within an Investment Banking compliance environment. Working closely with Legal, Compliance, Internal Controls, Technology, and Global Client Onboarding teams, this role advances the firm's reputation protection by ensuring all client records meet applicable local and global standards.

Role Responsibilities

• Perform review of client profiles checking for consistency across the full LifeCycle based on legal and commercial documents to understand client activity, structure, and associated risks.
• Obtain a general understanding of and execute AML policies and internal procedures in accordance with local and global principles.
• Address WKO organization inquiries regarding procedural and standards questions and engage appropriate teams.
• Prioritize and follow up on outstanding issues with multiple stakeholders, and foster partnerships with Legal, Compliance, Internal Controls, Technology, and Client Services teams.
• Prepare data and metrics for regulatory reporting and participate in special projects as requested.
• Maintain in-depth knowledge of procedures and systems to ensure client records are compliant with all applicable rules.

Knowledge Skills and Abilities

• Previous experience with AML and KYC in Investment Banking preferred, with excellent verbal, written, and interpersonal communication skills.
• Highly organized, proactive, and motivated with strong prioritization, innovation, and problem-solving skills.
• Ability to work well under pressure and tight deadlines with flexibility to accept new assignments and changing priorities.
• Proficient in Excel and PowerPoint, with knowledge of tools such as Alteryx, Tableau, BI, and UiPath considered an asset.
• Fluent English required in both written and verbal form, with Portuguese considered a plus.

Embedded within a cGMP-regulated laboratory organization, the Quality Control Analyst III performs physical, chemical, and biochemistry analysis of in-process, lot release, and stability samples while mentoring junior analysts and leading method qualification projects. Working closely with the broader QC team through LIMS, deviation investigations, and quality records, this role develops the analytical infrastructure that enables compliant product release across clinical and commercial programs.

Day-to-Day Responsibilities

• Perform physical, chemical, and biochemistry analysis of in-process, lot release, and stability samples, and review analytical results in LIMS or other computerized systems.
• Train and mentor junior analysts and write quality records including deviations, CAPAs, and Change Controls, as well as test methods.
• Support and lead projects such as method transfers, new instruments, and method qualification.
• Perform lab and deviation investigations and write investigation reports.
• Perform equipment maintenance and calibrations as required.

Education and Experience

• Bachelor's or Associate's degree in Microbiology, Biochemistry, or a related science field.
• 3-5+ years of industry experience, preferably in a cGMP environment.
• Experience in protein analysis techniques such as ELISA, qPCR, CE-SDS, and Isoelectric Focusing.
• Experience with GMP Quality Systems including TrackWise and LIMS, and proficiency in Microsoft Office Suite.
• Excellent ability to communicate in written and verbal format, interpret data, prioritize tasks, and work effectively in a team setting.

Reporting to site Quality leadership, the Quality Control Analyst tests and inspects product components against performance and integrity criteria to ensure compliance with specifications and quality standards in the communications and electrical assembly industry. Partnering with production line teams and SQE to drive supplier improvements and lead 8D problem-solving, this role reduces Cost of Poor Quality and determines the suitability of product release.

Scope of Work

• Use 8D thinking to handle customer complaints and prevent repeated quality issues from occurring.
• Continuously improve in-process defects and reduce Cost of Poor Quality via workshop leadership.
• Lead efforts to solve quality problems on the production line and audit the production line to identify risks and work toward solutions.
• Support SQE to drive supplier improvement on material quality issues.
• Perform testing and inspection of products against performance and integrity criteria to ensure product quality and reliability.

Professional Experience

• Bachelor's degree in machinery, electrical engineering, or a related field.
• 5+ years of quality experience in assembly of communication or electrical industry, with experience in connectors preferred.
• Knowledge of molding, stamping, and plating processes, and familiarity with PFMEA, SPC, C and E, QC7, and 5WHY analysis tools.
• Knowledge of Six Sigma with proficiency in Minitab, Excel, and PowerPoint.
• Good English reading and writing skills with strong work ethic, sense of responsibility, and ability to work well under pressure.

Sitting at the intersection of compliance and client services, the Quality Control Analyst maintains complete and accurate client information across internal data systems while conducting screenings and background searches in accordance with Central Bank Guidelines and Global Group Policies. Operating across account onboarding, entity structure examination, and documentation review functions, this role ensures every client record meets internal branch standards, regulatory requirements, and global group controls.

What You'll Do

• Ensure the complete and accurate input, update, and maintenance of client information in all internal data systems.
• Perform detailed analysis and provide feedback on application kits for account opening, account updates, and account repapering.
• Examine natural and entity structures of varying complexity including individuals, corporate entities, funds, and trusts to support successful account onboarding and updates.
• Conduct and review screenings and background searches on new and existing clients in accordance with Central Bank Guidelines and Global Group Policies.
• Act as intermediary for RM and AM on client account documentation and client document queries.
• Support the Head of Department with activities related to team objectives and group projects.

Minimum Qualifications

• Bachelor's degree required.
• Anti-Money Laundering Certification such as ACAMS or equivalent required.
• Working knowledge of Microsoft Office Suite.
• Effective communication and presentation skills with efficient time management skills.
• Fluency in English and knowledge of other languages.

A key member of the Quality Control laboratory team, the Quality Control Analyst performs biopharmaceutical product testing using HPLC, spectrophotometric, and capillary electrophoresis methods to support stability programs, method validation, and new equipment introduction. Collaborating across QC and analytical development functions, this role contributes to compliant product release and laboratory capability growth in a GMP-regulated environment.

Work Activities

• Perform testing of biopharmaceutical products using HPLC, spectrophotometric, and capillary electrophoresis methods.
• Prepare, update, and complete product testing related documentation.
• Perform stability testing according to approved protocols.
• Participate in qualification, transfer, or validation of analytical methods.
• Select and introduce new analytical equipment to Quality Control laboratories and prepare related documentation.

Experience and Qualifications

• Bachelor's or master's degree in chemistry, biochemistry, bioengineering, or a related field.
• Experience with chromatographical and/or capillary electrophoresis methods preferred, with experience working with hazardous chemicals an advantage.
• Knowledge of GMP standards preferred.
• Analytical thinking and problem-solving abilities with strong accountability and commitment to professional development.
• Proficiency in English and Lithuanian required, with good understanding of MS Office.
• Ability to work as part of a multi-disciplinary team.

Program-level quality assurance for AMEDD's MODS program depends on the Quality Control Analyst, who leads quality assurance planning, conducts internal process audits, and drives root cause analysis for high-severity tickets and nonconformances across IT service management operations. Based within a defense-focused program team and serving as liaison for enterprise quality initiatives, this role delivers audit outcomes and compliance evidence that directly enable contract performance and regulatory inspection readiness.

Leadership Responsibilities

• Assist in establishing the quality management system and develop the quality assurance approach and plan across the program.
• Perform internal audits of technical accuracy of procedures, monitor weekly reports and monthly metrics, and document nonconformances.
• Support root cause analysis activities associated with high severity level tickets and outages, and facilitate investigation of operational problems with engineering and technical personnel.
• Participate in the development, maintenance, and refinement of internal quality controls and recommend, facilitate, track, and report on continuous process improvement activities.
• Review and approve contract deliverables including plans, procedures, reports, and CDRLs/SDRLs prior to release to the customer.
• Provide the program manager with timely metrics and audit outcomes, and report to higher-level management on quality achievements as liaison for enterprise quality initiatives.
• Assist with documenting, analyzing, performing, and interpreting new and/or modified system components and auditing enhanced processes.

Qualifications and Experience

• BA/BS degree with 4-8 years of relevant experience, or a Master's degree with 5-8 years of prior relevant experience in IT Service Management projects.
• Lean Six-Sigma Green Belt or Black Belt training and experience with implementing process improvements, with Certified Lean Six-Sigma Black Belt preferred.
• Experience auditing to external quality standards such as ISO or CMMI, with formal auditor training and Root Cause Analysis training preferred.
• Experience with conducting root cause analysis, collecting and analyzing metrics, and experience with Agile principles.
• Understanding of ITIL principles and Configuration Management principles, with knowledge of ServiceNow including Change Management, Asset Management, and CMDB with CI Lifecycle Management.
• Proficiency with MS Office products including Word, Excel, Visio, PowerPoint, and Project.
• Ability to acquire Public Trust and ADP2, with excellent verbal and written communication skills and ability to multitask in a fast-paced environment.

As the Quality Control Analyst, this role oversees aircraft airworthiness inspections, engine logbook reviews, and CARMAC System entries to ensure maintenance performance meets PAE, FAA, and DoD standards across both military and general aviation platforms. The Quality Assurance program relies on this work to maintain compliant forms, certifications, and corrective action records that safeguard airworthiness and operational readiness across assigned sites.

Strategic Responsibilities

• Ensure maintenance performance is according to PAE, FAA, and DoD standards and Technical Orders as appropriate.
• Ensure required aircraft airworthiness inspections are carried out and that forms and certifications for both military and general aviation aircraft are prepared.
• Monitor all required forms and reports related to aircraft, parts inventory, parts usage, and associated ground support equipment.
• Review aircraft and engine logbooks and monitor engine trend analysis, oil analysis, hydraulic sampling programs, and trends in aircraft material condition.
• Investigate repeat discrepancies, determine causes, and identify necessary corrective actions.
• Make entries into the CARMAC System using the Aircraft Maintenance Report or other required reports.
• Coordinate training and safety functions as required at selected sites and assist in general housekeeping and clean-up.

Background and Experience

• FAA Airframe and Powerplant certificate with a current Inspection Authorization and at least 1 year of experience in a similar full-time aircraft maintenance environment required.
• At least 5 years of recent full-time experience as an aircraft and powerplant mechanic.
• Above average working knowledge of both military and general aviation aircraft and systems, including aircraft and engine maintenance records and logbooks.
• Must possess thorough knowledge of PAE Quality Policies and Procedures and analytical ability to objectively evaluate job performance from a Quality and Safety aspect.
• Must be able to obtain a DoD Security Clearance of at least Secret and a valid passport with ability to perform worldwide travel on short notice.
• Strong verbal and written communication skills with the ability to read, write, speak, and understand English.

Quality Control Analyst refines the accuracy and compliance of QC test data generated at Contract Manufacturing Organizations by reviewing Drug Substance and Drug Product in-process, release, and stability data, authoring expiration dating documentation, and supporting method qualification across a biologics portfolio. The work directly supports regulatory submission readiness and external QC program integrity by ensuring CMO data trends and investigation reports are reviewed, verified, and reported to appropriate management.

Delivery Expectations

• Review and verify QC test data including Drug Substance and Drug Product in-process, release, and stability data generated at CMOs, and examine CMO data trends.
• Verify data in regulatory analytical files and reports and review investigation reports from CMOs, reporting any issues to the appropriate Manager.
• Support method qualification, validation, and method enhancement for products, and monitor and support change controls.
• Author expiration dating documentation for clinical and commercial Drug Product and Drug Substance.
• Assist in the development and improvement of SOPs and departmental policies and procedures, and conduct periodic review of new guidelines and regulatory developments.
• Assist with the Reference Standards function through technical review of data.

Professional Experience

• Bachelor's degree in a scientific discipline with at least 4 years of industry QC experience.
• Previous experience with Biologics highly preferred, with experience in microbiological techniques a plus.
• Basic knowledge in analytical chemistry across a wide range of technologies including HPLC, CE, and MS, with thorough understanding of GMPs, ICH guidelines, and regulatory guidelines.
• Working knowledge of stability programs and specifications setting required.
• Proficient in Windows and MS Office including Outlook, Word, Excel, and PowerPoint, with knowledge of Adobe, JMP, and SigmaPlot also required.
• Highly motivated and self-driven with strong problem-solving, negotiation, and communication skills, and ability to work independently to schedule, track, review, and report on complex external QC activities.

The Quality Control Analyst creates reliable analytical results for manufacturing support by conducting clinical and non-clinical laboratory studies under cGMP regulations per FDA and OECD guidance, troubleshooting testing failures, and maintaining laboratory equipment and documentation practices. Working alongside manufacturing and quality teams, this role enables compliant product release and continual laboratory improvement through corrective and preventive actions applied to raw material, API, and drug product testing programs.

Core Responsibilities

• Conduct analysis associated with clinical and non-clinical laboratory studies under cGMP regulations per FDA and OECD guidance.
• Review data for compliance to specifications, report results, and troubleshoot abnormalities.
• Troubleshoot, investigate, and resolve laboratory testing failures and drive solutions through corrective and preventive actions.
• Ensure equipment is performing well, coordinate preventative maintenance, and maintain inventory and ordering of laboratory supplies.
• Ensure good documentation practices are followed and exercise judgment within broadly defined practices and policies in selecting methods and techniques for obtaining results.

Education and Experience

• Bachelor's degree or equivalent in a life science-related field.
• 2+ years of quality control-related experience in a GMP environment.
• Experience supporting production of APIs, drug products, and raw material release, with knowledge of FDA regulations and guidelines.
• Knowledge of analytical equipment and instrumentation including UV, HPLC and UHPLC, LC/MS, GC, Karl Fisher Titration, and FTIR.
• Working knowledge of Microsoft Word and Excel, with personal leadership skills and ability to work well in teams.

Embedded within Launchworks' manufacturing area, the Quality Control Analyst executes QC procedures in compliance with ISO 13485 and 21 CFR 820 regulations by conducting incoming inspections, AQL sampling, and sub-assembly reviews throughout the production workflow. Working closely with QC Supervisors and production management, this role advances product conformance by identifying defects, producing non-conformance reports, and ensuring quality is built into every stage of the manufacturing process.

Key Responsibilities

• Maintain and execute the QC program and inspect AQL samples for defects during batch or production runs per QC work instruction procedures.
• Understand Bill of Material, Job Traveler, data specification sheets, technical documents, and manuals to ensure products and parts meet quality standards.
• Notify the supervisor and help analyze and correct production problems when defects are found.
• Work with the QC team to ensure QC is built effectively into the workflow and produce reports regarding inspection results and non-conformance of products or processes.
• Collaborate with QC Supervisor and/or QC Tech II and stop production when a QC issue requires immediate attention.

Qualifications and Experience

• Bachelor's degree preferably in life sciences, with ASQ, CQA, or CBA certification desired, and/or a combination of experience and training.
• Minimum 1 year of experience in a manufacturing or QC environment.
• Basic math and computer skills.
• Strong communication skills to present data for review.
• Drive, determination, and ability to participate as a team member to ensure demanding projects are handled smoothly and cooperatively.

Reporting to laboratory management, the Quality Control Analyst coordinates environmental monitoring of clean rooms and controlled areas by conducting microbial-based assays, particulate monitoring, and utility sampling across WFI, compressed gas, and nitrogen systems at an LA pharmaceutical facility. Partnering with QA, Manufacturing, and Analytical Development teams while potentially overseeing daily workflow for the assigned area, this role elevates GMP compliance by ensuring all monitoring results, deviations, and validation activities are accurately documented and resolved.

Core Functions

• Perform environmental monitoring of clean rooms and controlled areas, including viable, non-viable, surface, and personnel sampling, as well as microbial and particulate monitoring.
• Conduct microbial-based assays including bioburden testing, biological indicators, growth promotion, water group analysis, and organism identification, and read and interpret microbial plate results.
• Use Global LIMS or other computerized systems to enter and approve test results, and perform review of test data with application of GDP.
• Perform change requests such as ECR and DCR, assure SOPs are updated, and identify and issue Alert and OOL forms for out-of-limit results.
• Maintain the laboratory area in a GMP state following all EHS and 5S guidelines, operate and maintain laboratory equipment, and ensure equipment maintenance is documented.
• Investigate deviations, write exception documents, and support execution of validations for lab equipment, lab methods, or facility projects.
• Provide training and work direction for assigned areas and contribute to team settings to increase efficiency, improve quality, and support new product development.

Required Qualifications

• Bachelor's degree in chemistry, biological science, or a related technical field.
• Some related work experience with demonstrated working knowledge of assays and equipment in the functional area.
• Understanding and ability to perform aseptic and relevant microbiological methods, with prior experience in a classified clean room desired.
• Working knowledge of applicable CTPs and SOPs, EHS requirements, and application of cGMP and GDP standards.
• Good project management skills with the ability to guide people, encourage teamwork, and teach assays.

Sitting at the intersection of digital quality assurance and marketing technology, the Quality Control Analyst ensures the accuracy and functionality of marketing automation platforms and workflow technologies by executing system validation, regression testing, and defect logging across web- and mobile-based environments. Operating across the Centralized Operations QC department and Risk and Resolutions teams, this role safeguards digital campaign consistency and downstream system integrity for an organization committed to inclusive and equitable practices.

Primary Duties

• Ensure accuracy and correct functionality of multiple systems using standard rules, procedures, testing, and validation, and ensure existing applications interact correctly with the database using best practices.
• Troubleshoot and support system issues, working closely with Risk and Resolutions on appropriate communication to stakeholders.
• Identify potential impacted areas to existing downstream functionality, present risk when needed, and identify and log defects as required.
• Create testing scenarios for functional and performance purposes and validate user interface components with technical solutions.
• Support root cause identification of issues and ensure consistency of digital campaigns including all associated emails and landing pages per company standard QC guidelines.

Skills and Qualifications

• Bachelor's degree with 2+ years of direct QA experience in a web- or mobile-based development environment, and 5+ years of direct QC experience preferred.
• Experience with testing methodologies of complex systems, regression testing, and familiarity with GUIs and coding knowledge.
• Experience with marketing technologies and working in a cloud-based environment.
• Strong problem-solving skills with the ability to analyze issues creatively, and experience using Excel for quantitative analysis.
• Excellent oral and written communication skills with detail orientation, adaptability to changing priorities, and ability to work independently and collaboratively.
• Commitment to valuing diversity, practicing inclusive behaviors, and contributing to an equitable working and learning environment.

A key member of the compliance and audit support team, the Quality Control Analyst performs quality audits of departmental files and processes to ensure adherence to investor, insurer, and regulatory guidelines across loan service transfers and acquisitions at Dovenmuehle. Collaborating with internal teams and external audit stakeholders while managing loan file reconciliation and process improvement identification, this role strengthens the organization's regulatory standing and the accuracy of mortgage servicing operations.

Operational Focus

• Perform quality audits and reviews in adherence to investor and insurer guidelines and applicable regulations, covering verbal and/or written communications and documentation.
• Verify the presence and accuracy of all documents required to prepare a transfer or acquisition, conducting research or contacting others to obtain corrected or missing information.
• Perform report reconciliations and handle applicable escalations in accordance with departmental and organizational guidelines.
• Manage and communicate information to internal teams and actively work with staff to prepare for internal and external audit processes.
• Update auditing documentation, maintain comprehensive knowledge of the organization's processes and procedures, and actively participate in identifying process improvement opportunities.
• Successfully complete annual regulatory compliance training and perform additional duties as assigned.

Technical Qualifications

• Bachelor's degree or equivalent combination of education and experience with mortgage servicing, processing, or underwriting experience.
• Internal auditing experience in the mortgage servicing or financial services industries, with experience with the Black Knight system preferred.
• Strong analytical and problem-solving skills with attention to detail.
• Ability to handle complex, multiple tasks in a fast-paced, deadline-driven environment.
• Proficient with Microsoft applications with effective verbal and written communication skills and the ability to explain complex matters clearly and concisely.

Consistent environmental and utility monitoring compliance across manufacturing processing areas in Gaithersburg, Maryland depends on the Quality Control Analyst, who performs viable and non-viable sampling, purified water system analysis, and non-conformance investigations in a cGMP laboratory setting. Serving as a day-to-day operational resource and collaborating with Quality Assurance, Manufacturing, and Analytical Development, this role guides laboratory readiness and regulatory compliance through accurate data management and equipment troubleshooting.

Activities

• Perform routine environmental and utility monitoring including viable, non-viable, surface, and personnel sampling, as well as compressed air and gas sampling.
• Operate appropriate monitoring, sampling, and testing equipment and identify and troubleshoot equipment and software problems, including LC systems.
• Compile and enter data into computer databases for reporting and trending purposes, and ensure written records are kept in accordance with cGMP and company procedures.
• Assist in writing, reviewing, and editing standard operating procedures and participate in the investigation of non-conformances in compliance with quality procedures and regulations.
• Maintain accurate lab inventories, order supplies as needed, and perform other duties as assigned.

Minimum Qualifications

• Bachelor's degree in a scientific discipline or equivalent years of relevant industry experience.
• Minimum 2 years of experience in a Quality Control cGMP laboratory, preferably in the pharmaceutical industry.
• GxP knowledge including GLP, GCP, and GMP required, with understanding and ability to perform aseptic and relevant microbiological methods.
• Prior experience in a classified clean room desired, with aseptic technique and ability to gown into a sterile environment.
• Experience with LabVantage or other LIMS platforms a plus.
• Excellent written and verbal communication skills with strong multitasking, organizational skills, and ability to work independently with minimum supervision.
• Ability to lift up to 20 lbs with frequent standing and walking in lab environments for extended periods.

As the Quality Control Analyst, this role coordinates individual workload and ensures that relevant data is checked, approved, recorded, and available for inspection in accordance with Good Manufacturing and Good Laboratory Practices across laboratory and office work areas. The broader QC laboratory relies on this work to maintain cGMP-compliant delivery, equipment qualification, KPI target performance, and audit readiness in support of regulatory authority inspections and continuous improvement programs.

Day-to-Day Responsibilities

• Ensure compliance with cGMP processes, documentation, and systems relevant to the assigned area and apply and maintain laboratory quality systems.
• Understand and follow all Health and Safety systems and ensure all work is consistent with safe working practices.
• Support the continuous development of wider QC operations and continuous improvement programs and identify and escalate focused improvements to activities within the section.
• Deliver assigned tasks to meet or exceed QC Key Performance Indicator targets and ensure QC equipment and systems are maintained, calibrated, and qualified to appropriate standards.
• Provide support to Regulatory Authority inspections and support QC Line Management as appropriate.
• Communicate issues effectively and appropriately to ensure timely resolution while maintaining the positive image of the organization.

Knowledge Skills and Abilities

• Bachelor's degree with 1 year of experience or relevant demonstrable skills.
• Excellent delivery of core QC skills with demonstrable or transferable skills relevant to QC activities.
• High level of accuracy and close attention to detail with good communication skills and the ability to present information clearly and concisely.
• Proficient in Microsoft Office with entrepreneurial skills in innovation and problem solving, tenacity, and ability to influence and demonstrate strong team working.
• Fluency in English required, with ability to work on own initiative and within a team environment.

Quality Control Analyst guides the accurate and timely testing of polyol products by coordinating specialized and non-routine testing programs, calibrating instruments, and reviewing laboratory data for trends and corrective actions in support of internal and external customer needs. The work directly supports process quality and product integrity by linking Operations, Quality Assurance, and laboratory resources through well-maintained SOPs, reagent qualification, and site-level Quality initiatives.

Scope of Work

• Coordinate and perform specialized and non-routine testing of polyol products to meet internal and external customer needs and departmental goals.
• Prepare and calibrate chemical reagents, maintain laboratory instruments, and ensure necessary laboratory supplies and equipment are available.
• Review laboratory data for accuracy and trends, communicate concerns to the laboratory manager, and implement agreed corrective actions, monitoring their effectiveness.
• Revise and update laboratory SOPs to meet evolving customer and business needs and stay current with scientific developments in areas of expertise.
• Work with Operations and Quality Assurance to understand current demands, identify, investigate, and resolve process discrepancies, and lead Quality projects and initiatives for the site.
• Provide guidance and training to new and junior QC Analysts.

Qualifications and Experience

• Bachelor's degree in Chemistry, Food Science, or a related field.
• Experience with analytical chemistry and chromatography with good working knowledge of laboratory practices.
• Strong oral, written, and computational skills with the ability to rapidly learn new skills and expand expertise into other areas of science.
• High energy, innovative, organized, positive attitude, and able to handle multiple tasks simultaneously in a team environment.
• Must be available for some weekend and after-hours coverage.

The Quality Control Analyst crafts a strong foundation of GMP-compliant testing by performing basic and advanced laboratory work including pH, osmolality, and plate-based potency methods for in-process support, release, and stability of clinical development and commercial products. Working within the QC organization and maintaining alignment with current SOP curriculums, this role enables safe and compliant product release by applying GMP principles, revising documents, and participating in continuous improvement projects.

Key Responsibilities

• Perform basic routine and non-routine testing and general QC laboratory work for in-process support, release, and/or stability of clinical development and/or commercial products in a GMP environment.
• Apply GMP principles on a daily basis and perform sample testing using basic test methods including pH, osmolality, and particulate matter, while training on more advanced plate-based methods.
• Perform maintenance of QC lab equipment, procedures, and systems and revise SOPs and other documents as needed.
• Identify and participate in continuous improvement projects and maintain training to current standards on all assigned curriculums.
• Comply fully with company health and safety procedures and practices.

Required Qualifications

• Associate's degree with 2+ years of experience in a relevant field, or a Bachelor's degree in a relevant field.
• Experience with basic lab equipment including pH meters, balances, and pipettes, with knowledge of biological and/or chemical handling.
• Experience with cell culture and plate-based assays and proficiency in sterile technique preferred.
• Experience authoring or revising SOPs and experience with LIMS or other sample and inventory management systems preferred.
• Broad experience with Microsoft Office products with high organization and attention to detail.

Embedded within a regulated QC laboratory environment, the Quality Control Analyst manages routine testing of raw materials, in-process samples, stability batches, and finished goods using LCMS, HPLC, Raman spectroscopy, and other chemistry methods to ensure product quality and customer satisfaction. Working closely with contract testing labs, operations, and customer-facing teams, this role advances product integrity by documenting and interpreting experimental data, managing reagent inventory, and investigating quality complaints.

Core Functions

• Conduct routine testing of raw materials, in-process, stability, and finished goods samples from manufacturing process steps.
• Conduct chemistry testing using LCMS, HPLC, UV/Vis, wet bench chemistry, TOC, Conductivity, Raman spectroscopy, and pH, among other methods.
• Conduct routine QC lab cleaning and maintenance, equipment preventive maintenance or calibration, and shipping inspection of finished goods.
• Manage QC reagent inventory, order reagents and supplies, and assist in QC reagent qualification and studies.
• Document, analyze, and interpret QC and experimental data and respond to internal and external customer inquiries relevant to product quality or integrity.
• Investigate customer complaints, obtain relevant QC data, and manage contract testing labs for in-process and final release assays.

Qualifications and Experience

• Bachelor's degree in Chemistry, Biochemistry, or a related scientific discipline and/or equivalent experience with 1+ years in a regulated Quality Control or similar role.
• Working knowledge of cGMP with analytical instrumentation experience including ESI-MS, LC-MS, HPLC, GC, bioburden testing, endotoxin testing, KF, and UV/VIS preferred.
• Strong communication skills with a high degree of attention to detail.
• Ability to identify customer needs and develop realistic solutions.
• Ability to communicate recommendations and decisions across the organization.