QUALITY ASSURANCE AUDITOR JOB DESCRIPTION

A batch released without adequate GMP documentation review can trigger an FDA warning letter, a product recall, or a clinical trial hold - outcomes that cost manufacturers months and millions to resolve. Preventing that sequence is the core charge of the Quality Assurance Auditor. This role owns the audit function within the QA department, covering internal manufacturing operations, external vendor qualification, and compliance with 21 CFR and ICH GCP standards. Scope varies by site but consistently includes CAPA ownership and regulatory inspection support.

Quality Assurance Auditors in pharmaceutical and life sciences manufacturing are accountable for planning, executing, and closing internal and external audits that verify sustained compliance with GMP and GCP regulatory requirements, with findings directly informing product release decisions and inspection readiness. Working within the QA function alongside regulatory affairs, production, and laboratory teams, the auditor carries ownership of CAPA lifecycle tracking and deviation investigation from initiation through closure.

Career Impact: Hands-on ownership of GMP audit programs - spanning batch record review, vendor qualification, and CAPA investigation - develops the domain depth that QA Manager and Regulatory Affairs Specialist roles in pharma and biotech actively require.

Business Impact: Audit findings in a regulated manufacturing environment carry the weight of product release decisions; rigorous execution of this role is what keeps finished goods moving to patients on schedule and inspections free of critical observations.

Growth Opportunity: Exposure spanning both GLP and GMP audit regimes, combined with regulatory inspection support and clinical trial vendor oversight, expands an auditor's scope toward Senior QA, QA Manager, or Compliance Director trajectories.

• Review and approve executed cGMP batch records, logbooks, and supporting manufacturing documentation to verify completeness and regulatory compliance.
• Prepare, conduct, and close internal and external audits of vendors, suppliers, contract manufacturers, and service providers against applicable GMP and GCP standards.
• Initiate, track, and close Deviations, Change Controls, CAPAs, and Out of Specification events within committed regulatory timelines.
• Audit internal process compliance through system and procedure reviews, identifying gaps and escalating significant findings to QA management.
• Support regulatory inspection preparation, coordination, and follow-up, including documentation review and response to agency inquiries.
• Revise and manage SOPs and other controlled procedural documents to reflect current regulatory requirements.
• Employ risk identification and mitigation strategies to address identified compliance gaps before they reach regulatory significance.
• Communicate audit outcomes and CAPA status to project teams, QA leadership, and external vendor or client contacts.

• Bachelor's degree in life sciences, biology, chemistry, or a related scientific field, or equivalent work experience.
• Three or more years of Quality Assurance experience in a GMP-regulated pharmaceutical, biotechnology, or biopharmaceutical environment.
• Working knowledge of current Good Manufacturing Practices (21 CFR Parts 210 and 211) and ICH GCP principles.
• Experience planning and conducting internal and external audits, including vendor qualification and CAPA investigations.
• Familiarity with deviation management, batch record review, and out-of-specification investigation processes.
• Ability to prepare accurate, logically organized written materials including audit reports, CAPA responses, and controlled documents.
• Strong analytical and organizational skills with demonstrated ability to manage multiple concurrent audit activities.

• Experience working in or auditing ISO-classified cleanroom environments (ISO 5 through 8) within a biopharmaceutical manufacturing setting.
• Familiarity with EU GMP regulations including Annex 1, 11, and 13, in addition to US CFR requirements.
• Exposure to GLP laboratory audits or clinical trial vendor oversight covering central laboratory services or EDC systems.
• Experience supporting FDA or equivalent regulatory agency inspections as a documentation reviewer or subject matter coordinator.

• CAPA closure rate within committed timelines, reflecting audit follow-through on deviation resolution.
• Repeat observation rate across successive audit cycles, measuring whether root cause corrections hold.
• Batch record deficiency rate, tracking how often reviewed documentation requires correction before release.
• Regulatory inspection observation count, reflecting the audit program's contribution to inspection readiness.
• Vendor audit completion rate against the annual audit schedule, measuring coverage of the qualified supplier base.
• Typical tools: electronic quality management systems (commonly Veeva Vault QMS or MasterControl); office productivity software (commonly Microsoft Word, Excel).

• Base Salary Range: $65,000 to $95,000 annually, depending on experience and industry segment.
• Bonus: annual performance bonus of 5% to 10% of base salary.
• Equity: stock options or RSUs common at biotech and emerging pharma employers.
• Health Benefits: medical, dental, and vision coverage; employer contributions standard.
• PTO: 15 to 20 days annually, plus company holidays and sick leave.
• Common Perks: tuition reimbursement, professional certification support, relocation assistance for site-based roles.

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

Employment in regulated pharmaceutical and life sciences environments is contingent on successful completion of a background check, which may include criminal history and verification of credentials. All applicants are considered without regard to race, color, sex, religion, national origin, age, disability, genetic information, veteran status, or any other characteristic protected under applicable federal, state, or local law. Candidates must hold current authorization to work in the United States. Qualified individuals requiring accommodations during the application or employment process may request them at any time.

The Quality Assurance Auditor owns internal and external audit coverage across assigned line stations, conducting scheduled and unscheduled surveillance of vendors and sub-contractors for compliance with Federal Aviation Regulations and Repair Station Policies. Reporting to the Quality Assurance Manager, this auditor works with management across departments to lead corrective action plans and supports yearly audit planning, enabling sustained regulatory compliance and a culture of safety across the repair station network.

Key Responsibilities

• Conduct internal and external quality audits of assigned line stations, documenting results and identifying hazards and associated risks.
• Monitor compliance with company Repair Station Policies and Procedures, Safety Management System (SMS), and Training Program requirements using QA and SMS auditing tools.
• Identify systemic problems with respect to policies and procedures and report deficiencies.
• Conduct scheduled and unscheduled surveillance and audits of vendors and sub-contractors for compliance with FEAM policies and Federal Aviation Regulations.
• Perform investigations into maintenance errors and quality escapes as needed.
• Initiate and coordinate Corrective Action Plans (CAPs), working with management to resolve issues and assist in the corrective action process for internal and external customers.
• Review corrective action plan responses to ensure they adequately address the root cause of issues and incidents.
• Perform effective Root Cause Analysis.
• Monitor Line and Service checks randomly to ensure proper procedures and paperwork are utilized.
• Audit work packages to ensure all assigned work has been properly completed and documented.
• Research and retrieve technical data, properly interpreting drawings and other technical documentation.
• Maintain audit and investigation records and assist with yearly audit planning.
• Maintain the Repair Station Approved Vendor List and foster a culture of quality, safety, and compliance.
• Travel to line stations within the system to perform duties and perform other duties as assigned.

Education & Experience

• Degree in Aerospace, Aviation Maintenance, or equivalent industry-related work experience.
• FAA Airframe and Powerplant License (A&P) with no history of infractions.
• Minimum five years of CFR Part 145 repair station or 121 air carrier Maintenance, Quality Assurance, or Inspection experience, including at least two years of internal auditing experience in the aviation industry.
• Familiarity with FAA regulations 14 CFR 43, 145, and 121.
• Understanding of Safety Management System (SMS) and Root Cause Analysis (RCA).
• Proficiency in Microsoft Office Suite (Word, Excel, Outlook).
• Ability to produce articulate and well-written reports and communicate effectively both orally and in writing.
• Ability to interface professionally with all departments, levels of management, customers, and vendors; strong analytical, problem-solving, critical thinking, and organizational skills.
• Must have a valid driver's license, valid passport with no travel restrictions, and authorization to work in the US.
• Must be willing to travel over 25% of the time and work an irregular schedule when required.

Embedded within the Quality Assurance function, the Quality Assurance Auditor II delivers technical support in evaluating processes, procedures, and trial conduct to ensure compliance with ICH GCP principles and regulatory requirements across clinical research activities. Working closely with project teams, QA management, and external clients, this auditor builds and maintains effective working relationships throughout the organization while providing quality assurance-related solutions to both internal and external customers.

Core Functions

• Maintain working knowledge of regulatory requirements, ICH GCP principles, and clinical trial processes.
• Prepare audit plans and support or conduct audit activities including client, clinical site, key document, database, trial master file, and software and system validation audits.
• Support or conduct audits of clinical trial vendors providing services such as central imaging, laboratory services, ECG reading, IP management, IRB review, and EDC systems.
• Evaluate internal compliance with company procedures, policies, GCP, and applicable regulations through system and process audits.
• Assist in the preparation, coordination, documentation, and follow-up of regulatory inspections.
• Assist in the creation, review, revision, and management of procedural documents.
• Communicate and report audit outcomes clearly and escalate significant compliance concerns to project teams, QA, management, and client contacts.
• Provide ad hoc regulatory compliance guidance and quality improvement consultation to internal and external customers.
• Report, manage, and follow up on deviations, complaints, issues, non-conformances, and related CAPAs.
• Employ risk identification and mitigation strategies related to identified and potential compliance issues.

Model Rho's Core Values.

Required Qualifications

• BA/BS in life sciences, social sciences, or a related field with at least four years of experience actively supporting clinical research, including two years of QA experience.
• Working knowledge of and experience with GCP.
• Proficiency in Microsoft Excel, Word, and PowerPoint.
• Strong verbal and written communication skills with the ability to understand and coordinate multiple projects.
• Ability to prioritize, remain organized and detail-oriented, and demonstrate strong analytical and problem-solving skills.
• Strong interpersonal skills; must be a team player with integrity, commitment to quality, and ability to think critically and creatively.
• Ability to maintain a high level of accuracy, make timely decisions, and work both independently and as part of a team.

Reporting to the Manager of Quality Assurance, the Quality Assurance Auditor leads review and approval of executed cGMP documentation and conducts internal and external vendor audits across two manufacturing facilities in the Baltimore area. Partnering with manufacturing operations, regulatory affairs, and laboratory teams, this auditor supports FDA inspections and cGMP training programs, enabling product release decisions that meet 21 CFR Parts 210 and 211 and EU regulatory standards.

Primary Duties

• Review and approve executed cGMP documentation and other documents relating to cGMP activities.
• Prepare, execute, and follow up on internal and external vendor, supplier, and service audits.
• Initiate new SOPs and revise existing SOPs as needed.
• Initiate, track, and close Deviations, Change Controls, CAPAs, and Out of Specification events.
• Review and approve cGMP logbooks and raw materials for use in cGMP manufacturing and testing.
• Perform line and room clearances and assist in FDA inspections regarding regulated activities.
• Stay current with CFR, FDA guidance documents, and EU regulations to ensure compliance policies are up to date.
• Assist in product label preparation and present cGMP training programs.
• Participate as QA floor representative during manufacturing operations.

Qualifications & Experience

• Bachelor's degree in life sciences, preferably biology or chemistry, or equivalent work experience.
• Two or more years of experience in a cGMP Quality Assurance role in the pharmaceutical, biotechnology, or biopharmaceutical industry.
• Strong understanding of current Good Manufacturing Practices (21 CFR Parts 210 and 211) and familiarity with EU Regulations (Annex 1, 11, and 13).
• Experience with batch record review, out of specification results, and CAPA investigations.
• Capable of gowning into and performing QA functions in ISO 5, 6, 7, and 8 classified cleanrooms.
• Strong computer skills including Microsoft Office (Word, Excel, Outlook, Access); knowledge of electronic documentation Quality Management Systems a plus.
• Ability to prepare accurate, clear, logical, and well-organized technical and complex written materials.
• Able to lift and carry 20 lbs.
• Travel between two CEL-SCI cGMP facilities in North Baltimore and Elkridge, MD; occasional weekend and evening work required.

Sitting at the intersection of batch record integrity and product release decisions, the Quality Assurance Auditor audits executed Manati and CMO batch records and GMP documentation to issue release or reject recommendations to the Sr. QA Manager. Operating across manufacturing operations and incoming materials review, this auditor collects trending data to support Right First Time initiatives and ensures GMP retention and stability samples are collected prior to finished product release.

Duties

• Issue on request Manati Batch Records.
• Audit executed Manati and CMO batch records and supporting documentation and issue release or reject recommendations to the Sr. QA Manager.
• Collect applicable trending data for the review process and advise of potential adverse trends; use trend data to support Right First Time (RFT) initiatives in the manufacturing area.
• File executed Batch Records and related documentation.
• Participate in the design and improvement of Master Batch Record templates to improve RFT initiatives.
• Audit GMP documentation for the release or reject of Incoming Materials.
• Assure the collection of GMP retention samples and stability samples prior to recommendation for release of finished product.
• Assure compliance with internal procedures.

Skills & Qualifications

• Bachelor's Degree in a Science discipline, preferably Chemistry or Microbiology.
• Minimum five years of experience in a GMP industry; pharmaceutical manufacturing experience required, with oral solid dosage experience preferred.
• Solid knowledge of cGMPs and FDA Guidelines; familiarity with process excellence and Lean methodologies preferred.
• Ability to take initiative and apply innovative problem-solving approaches in a fast-paced, changing business environment.
• Computer literate with knowledge of statistics.
• Fully bilingual in English and Spanish required.

A key member of the quality assurance team, the Quality Assurance Auditor establishes and documents tailored quality plans, evaluates work products, and gathers defect metrics data to support process compliance and improvement initiatives for an assigned area. Collaborating across project teams, customers, and support personnel, this auditor escalates unresolved issues to the appropriate level and participates in special projects and external audits to advance quality assurance goals.

Functions

• Assist in establishing and documenting a tailored quality plan for the performance of quality assurance activities for assigned area.
• Develop and maintain standardized quality assurance documentation including quality metrics for assigned area.
• Ensure documentation complies with standards, policies, procedures, and best practices.
• Support assessments and evaluations through analysis and interpretation of evidence to verify compliance to standards and applicable quality plans.
• Assist in determining level of process and product quality, report findings, and escalate unresolved issues to the appropriate level.
• Evaluate work products to assess quality, research alternative solutions, and make verbal or written recommendations to appropriate parties.
• Gather and review defect metrics data on a regularly scheduled basis and communicate findings and recommendations.
• Participate in special projects, external audits, and process improvements in support of quality assurance initiatives.

Requirements

• High school diploma or G.E.D.
• Four or more years of experience working with quality assurance and/or process improvement methodology.
• Experience working with quality metrics, data collection and analysis techniques, and standard quality assurance principles and assessments.
• Strong organizational, time management, and analytical skills.
• Good communication and interpersonal skills for interacting with team members, customers, and support personnel.
• Proficiency in personal computer and business solutions software.
• Ability to work independently and as part of a team, manage change, and complete responsibilities within a given timeframe and budget.

Sustained compliance with FDA GLP, GMP, and GCP regulations in a bioanalytical testing environment depends on the Quality Assurance Auditor, who facilitates audit management, hosts regulatory inspections, and maintains QA relationships with external clients for a laboratory specializing in large molecule bioanalysis. Based within the Raleigh-Durham, NC area and serving top-25 global pharmaceutical and biotech partners, this auditor issues QA statements for reports and performs duties with minimal QA management oversight.

Accountabilities

• Issue QA statements for reports as needed.
• Assist in hosting regulatory inspections by acting as scribe, reviewing documents, and coordinating with operational staff to answer questions.
• Assist in writing and reviewing QA standard operating procedures.
• Positively impact the company through active participation and identification of compliance gaps.
• Obtain and maintain professional and technical knowledge through educational workshops, professional publications, and personal networks.
• Assist in document management activities.
• Perform duties with minimal QA management oversight.

Experience & Qualifications

• Bachelor's degree in biology, chemistry, biochemistry, or a related field.
• Minimum three years of experience in the field or a related field, including at least one year in an environment subject to FDA GLP, FDA GMP, and/or FDA GCP regulations.
• Internal and/or external GxP auditing experience.
• Ability to perform QA audits, inspections, and monitoring procedures against SOPs, methods, protocols, guidance documents, and regulations.
• Excellent oral and written communication skills.
• Ability to manage multiple projects simultaneously in a fast-paced environment.

As the Quality Assurance Auditor, this role receives jobs from production areas for inspection, validates new products, and audits client mail kits to ensure QA standards and compliance requirements are met across a global aerospace and defence company's print and mail operations. The Quality Assurance team relies on this work to maintain 5S workstation standards, capture excessive error patterns for supervisor review, and support process efficiency projects that serve clients on site and touring potential clients.

Scope of Work

• Maintain general understanding of client's finished mail kit products and the JAAMS system for audit input.
• Receive jobs from production areas for inspection and perform QA validation for new products.
• Follow card validation processes when the customer is on site and provide demonstration of the JAAMS system to touring potential clients.
• Provide feedback to manager or supervisor on any excessive errors discovered.
• Ensure all audited work is forwarded to the appropriate area and maintain a clean workstation per 5S standards.
• Participate in various projects to improve process efficiencies and perform other duties as assigned by the Quality Supervisor.
• Understand and follow QA procedures while auditing all client mail kits and perform different tests to ensure QA standards and requirements meet compliance.

Background & Experience

• High school diploma or equivalent.
• Six to twelve months of quality assurance experience.
• Demonstrated knowledge of mail packaging machines and shipping methods including UPS, FedEx, and DHL.
• Hands-on experience using a job tracking system.
• Basic computer skills with knowledge of MS Office and Outlook.
• Strong problem-solving skills, excellent written and verbal communication skills, and high attention to detail.
• Highly organized, able to multi-task, and flexible to cross-train in other quality areas.
• Ability to lift up to 50 pounds, stand 100% of the shift, and work weekends as needed.

Quality Assurance Auditor coordinates and schedules internal and external audits, maintains audit records, and serves as the primary company representative for all technical and regulatory audit matters in an MRO aviation environment. The work directly supports compliance with aviation-specific laws and quality management processes, enabling production performance targets to be met through quality workshops, supplier desktop audits, and effective corrective action tracking.

Technical Responsibilities

• Coordinate and schedule internal and external audits and maintain audit records.
• Plan, lay out, and coordinate the site Quality Plan and Audit Schedule.
• Serve as primary contact and company representative for all technical and regulatory audit matters.
• Conduct audits, initiate and track progress on corrective actions, and respond to and verify the effectiveness of corrective actions from external audits.
• Conduct quality workshops and support colleagues to maintain quality, safety, and production performance targets.
• Work with suppliers, conducting desktop audits.
• Work with Quality Management Tools such as IQ MOVE, Q-Star, Q-scan, and eDoc, and interface with ERP supporting systems such as SAP.

Professional Experience

• Qualified engineer in a relevant specialist field such as mechanical engineering or electronics, or equivalent knowledge as a qualified technician with required years of relevant professional experience.
• Knowledge of aviation-specific laws and quality management processes.
• Experience with implementing and adapting norms and procedures, and conducting audits.
• Proficiency in Quality Management Tools (IQ MOVE, Q-Star, Q-scan, eDoc) and ERP systems such as SAP.
• Strong verbal, written, and interpersonal communication skills with good English proficiency.
• Good technical aptitude and business acumen.

The Quality Assurance Auditor produces operational and compliance audit findings, facilitates quality investigations, and conducts in-depth audits of production facilities within a regulated cannabis manufacturing environment governed by GLP, GMP, and HACCP standards. Reporting to QA leadership within Aurora Cannabis, this auditor performs inventory reconciliation, investigates deviations, and assigns corrective actions while moving between on-site production buildings to execute in-process checks.

Key Responsibilities

• Participate in operational and compliance audits on a regular basis and record and report findings.
• Perform in-process checks as needed.
• Facilitate quality investigations and report findings appropriately.
• Conduct in-depth audits of production facilities, including oral communication with staff and follow-up with key personnel.
• Perform inventory audits and reconciliation within operational areas.
• Investigate deviations and assign corrective actions.

Qualifications & Experience

• Bachelor of Science in biological or chemical science, or a related diploma, with a minimum of three years of experience in a regulated (GLP, GMP, HACCP) manufacturing environment.
• Knowledge of SOP and form updates and implementation; knowledge of cultivation practices is an asset.
• Strong problem-solving, decision-making, and scientific writing skills.
• High degree of personal integrity.
• Ability to interpret procedure manuals and operating instructions.
• Knowledge of computer hardware and software including spreadsheets and word processing applications.
• Ability and willingness to move between on-site production buildings.

Reporting to QA leadership, the Quality Assurance Auditor oversees weekly quality assessments across a global organization, analyzing quality data and monitoring trends to drive improvements to policies, procedures, and support site programs. Collaborating across leadership, PR, and cross-functional teams, this auditor delivers case reviews tailored to varied audiences, maintains an internal knowledge base, and may develop quality programs for new products and international support sites.

Day-to-Day Responsibilities

• Conduct weekly quality assessments across the global organization encompassing complex workflow processes.
• Track and flag trends and patterns within the assessments.
• Provide coaching and training sessions with the team.
• Identify root causes for urgent errors and create proposals to reduce them in the future.
• Analyze quality data to suggest improvements for policies and procedures.
• Monitor quality trends and perform quality improvement plans.
• Maintain an internal knowledge base and remain up to date on workflow changes, operational guidelines, and policy updates.
• Create and present case reviews that adapt to various audiences (leadership, PR, cross-functional etc.)
• Develop quality programs for new products and new support sites and may travel internationally when needed.

Knowledge Skills & Abilities

• BA/BS degree or equivalent with three or more years of experience in support, quality assurance, or a similar operational role.
• Experience initiating and driving projects to completion with minimal guidance.
• Knowledge of SQL or equivalent and strong Excel skills.
• Strong analytical skills and comfort analyzing data and conducting root cause analysis.
• Experience evaluating standard operating procedures and making recommendations for improvement and streamlining.
• Strong desire to collaborate, share, and drive best practices cross-functionally and globally.
• Demonstrated ability to communicate with a variety of audiences; self-starting and comfortable operating in ambiguity.