QUALITY ASSURANCE ASSOCIATE JOB DESCRIPTION

A Quality Assurance Associate owns the compliance infrastructure that keeps a biopharmaceutical or medical device product moving toward market. That ownership is narrower than it sounds - and harder. This role answers directly to the requirements of cGMP, FDA 21 CFR, and EU regulatory frameworks, translating those obligations into daily decisions about raw material release, deviation investigations, and supplier assessments that no other team member is positioned to make. Four words capture what the work demands: judgment under regulatory pressure.

As the Quality Assurance Associate, you will maintain GMP compliance across manufacturing operations, CMO partnerships, and internal quality systems, directly supporting product disposition and regulatory readiness for clinical or commercial biopharmaceutical and medical device programs. You will operate within a quality function that spans raw material qualification through finished product release, reporting to a Quality Director or senior QA lead while partnering with operations, regulatory affairs, and external manufacturing stakeholders.

Career Impact: Hands-on ownership of APQR coordination, deviation management, and regulatory inspection response builds the kind of documented compliance track record that advances careers toward QA Manager or Regulatory Affairs roles in the life sciences sector.

Business Impact: When incoming material assessments and DHR reviews are thorough and timely, patient-bound products reach distribution without the compliance holds that cost manufacturers weeks of lost output and regulatory credibility.

Growth Opportunity: Exposure to both CMO oversight and internal site quality - across clinical and commercial-stage programs - expands your scope from procedural execution to risk-based quality strategy, the competency that drives seniority advancement in GMP environments.

• Define critical quality attributes and processing parameters to support translation of commercial product requirements into approvable technical profiles.
• Approve instruction sets, specifications, and QA procedures governing incoming quality, manufacturing operations, and other cGMP-regulated activities.
• Investigate deviations from established procedures, documenting root cause determinations and corrective actions within required timelines.
• Assess starting materials, packaging components, intermediates, and finished product to authorize Quality approval or rejection consistent with GMP requirements.
• Coordinate Annual Product Quality Reviews and monthly Quality Management Review meetings, reporting site metrics and driving corrective action where control limits are exceeded.
• Manage the self-inspection program for the manufacturing or distribution facility, including finding documentation, response tracking, and verification of corrections.
• Support regulatory agency inspection readiness, including site preparation activities and formal response processes following inspection observations.
• Perform data integrity reviews of electronic raw data against reported results to support compliant raw material release decisions.

• Bachelor's degree in microbiology, chemistry, biochemistry, or a related life sciences field, or equivalent work experience.
• 3 or more years of experience in GMP manufacturing quality operations, with demonstrated competency in deviation management and product disposition.
• Working knowledge of FDA 21 CFR regulations and cGMP requirements applicable to biopharmaceutical or medical device manufacturing environments.
• Experience authoring or reviewing standard operating procedures and conducting product-related investigations in a regulated manufacturing setting.
• Familiarity with ISO 13485, EU regulatory frameworks, or international regulatory agency inspection processes.
• Ability to perform risk assessments in response to quality system failures, regulatory observations, or process deviations.
• Strong technical writing skills, with demonstrated ability to synthesize analytical data into compliant recommendations and summary documentation.

• Experience supporting viral gene therapy programs or orphan disease indications within a GMP manufacturing context.
• Prior involvement in external CMO quality oversight, including change control, technology transfer, and clinical product disposition.
• Exposure to regulatory agency inspections - FDA, EMA, or equivalent - including participation in site preparation or written response activities.
• Familiarity with phase-appropriate, risk-based quality principles applied across early-to-late clinical development programs.

• Deviation closure rate within target timeframe, reflecting timely root cause determination and CAPA implementation.
• Raw material release cycle time, measuring efficiency of incoming assessment and Quality disposition decisions.
• APQR completion rate against annual schedule, tracking adherence to regulatory reporting obligations.
• Audit finding repeat rate, indicating whether corrective actions from self-inspections and external audits are effectively sustained.
• DHR review accuracy rate, reflecting thoroughness of device history record assessments prior to product release authorization.

• Base Salary Range: $65,000 to $90,000 annually, depending on experience and location.
• Bonus: Annual performance bonus of 5% to 10% of base salary.
• Equity: Equity participation uncommon at this level; may vary by employer.
• Health Benefits: Medical, dental, and vision coverage; employer contribution standard.
• PTO: 15 to 20 days annually, plus company holidays.
• Common Perks: Tuition reimbursement, professional certification support, and on-site or hybrid flexibility where operations allow.

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

Employment contingent on successful completion of a background check and, where applicable, drug screening consistent with regulated manufacturing standards. All qualified applicants will receive equal consideration without regard to race, color, religion, sex, national origin, disability, veteran status, or any other characteristic protected under applicable federal, state, or local law. Reasonable accommodations are available to individuals with disabilities throughout the application and employment process. Candidates must be authorized to work in the United States.

The Quality Assurance Associate owns the implementation and maintenance of robust Quality Systems for a viral gene therapy manufacturing site, including cGMP compliance, raw material qualification, APQR coordination, and regulatory inspection support. Partnering with operations, supplier management teams, and regulatory agencies, the Quality Assurance Associate enables the transition of novel gene therapies from development into commercially approved products.

Key Responsibilities

• Provide strategic quality input on translating commercial product requirements into a technical product profile, including defining CQAs and CPPs.
• Approve all instruction sets, specifications, and Quality Assurance procedures related to incoming quality, operations, and other cGMP activities.
• Ensure all deviations from established procedures are appropriately documented and investigated to determine and fix root cause.
• Ensure all required assessment is carried out to support Quality approval or rejection for starting materials, packaging materials, intermediates, bulk, and finished product.
• Handle complaints at the site level and participate in the self-inspection program for the manufacturing facility, managing findings, responses, and corrections.
• Perform data integrity review of electronic raw data against reported data to support raw material releases.
• Participate in site inspection preparation and response processes for regulatory agencies.
• Coordinate completion of Annual Product Quality Review (APQR) reports for marketed products.
• Create and lead monthly Quality Management Review (QMR) meetings to review site metrics, ensure a state of control, and drive corrective action where appropriate.

Required Qualifications

• Minimum B.S. degree in microbiology, chemistry, or biochemistry.
• 3-5 years of experience in biopharmaceutical GMP manufacturing operations preferred.
• Experience with viral gene therapies and/or orphan disease indications is a plus.
• Knowledge of FDA and EU regulations and experience with US and international regulatory agency inspections.
• Direct experience reviewing and/or authoring SOPs and partnering with operations on product-related investigations and deviations.
• Excellent oral and written communication skills with strong technical writing experience required.
• Ability to synthesize data and summarize outcomes to provide recommendations on a compliant path forward.

Embedded within the Engineering team, the QA Associate delivers comprehensive quality coverage across all products built and maintained by the production studio, from requirements gathering through test plan execution and defect resolution. Working closely with development teams, project managers, end users, and suppliers, the QA Associate safeguards release standards and ensures every product fulfills client requirements and internal quality benchmarks.

Core Functions

• Test products and projects to ensure client requirements and briefs are fulfilled.
• Implement a strong layer of quality control across all existing and new products maintained and developed.
• Prepare and maintain test plans and scripts repurposed and scaled as part of the ongoing QA program.
• Research, suggest, and push testing tools and methodologies to improve what is tested and how.
• Work with QA and engineering teams to improve testing efficiency and effectiveness, introducing automated test suites where appropriate.
• Share real-time feedback to engineering and delivery teams on product defects and retest fixes.
• Liaise with suppliers, team leaders, and engineers on QA requirements at all junctures of the product development lifecycle.

Skills & Qualifications

• Highly analytical with the ability to clearly articulate findings to secure the right remedy.
• Detail-oriented with a proven ability to identify defects others may miss.
• Solutions-focused and confident in taking ownership of problems through to resolution.
• Able to communicate and adapt language based on audience to secure buy-in to QA requirements.
• Committed advocate for QA integrity, willing to push back when quality may be compromised.
• Continuous improver, enthusiastic learner, and collaborative team player with courage to embrace risk and patience to bring teammates and clients along.

Reporting to senior quality leadership, the Quality Assurance Associate shapes GMP compliance across CMO networks by managing quality oversight of clinical products through packaging, storage, distribution, disposition, and change control for small and large molecule drug programs. Partnering with External Manufacturing Operations, Clinical Supply Chain, Regulatory Affairs, and Technical Development, the Quality Assurance Associate enables compliant, efficient delivery of clinical assets from early to late phase.

Primary Duties

• Oversee quality aspects of GMP activities for clinical products packaged, stored, and distributed through CMO networks, including disposition, packaging support, exceptions management, change control, risk management, technology transfer, and validation.
• Provide quality expertise to influence tactical decisions needed to package and disposition product in compliance with GMPs.
• Support initiatives to improve systems and processes in Global Quality with goals of compliance, efficiency, and standardization.
• Perform risk assessments in response to product and quality system failures, investigations, and regulatory inspections.
• Perform tasks and make decisions consistent with cGMPs, GDPs, and quality governance, and collect and perform trend analysis for KPIs.
• Serve as primary quality contact for onboarding new clinical assets, product and process transfers, scale-up and validations, disposition, exceptions, change control, and risk management.
• Lead and/or support continuous improvement initiatives related to QMS and procedures for CMO and partner oversight.
• Collaborate with internal and external functions including External Manufacturing Operations, Clinical Supply Chain, Regulatory Affairs, and Technical Development to ensure cGMP compliance.
• Perform additional duties as assigned.

Qualifications & Experience

• Strong knowledge of quality operations and phase-appropriate, risk-based quality principles.
• Ability to develop strong relationships with internal and external counterparts.
• Strong verbal and written communication skills.
• Effective interpersonal skills with a collaborative, team-oriented approach.
• Solutions-oriented and comfortable working in a fast-paced environment with ambiguity and changing priorities.
• Ability to think creatively to influence and drive continuous improvement efforts.

Sitting at the intersection of regulatory compliance and manufacturing operations, the Quality Assurance Associate leads device history record reviews for da Vinci systems, instruments, and accessories, certifying compliance to product specifications, traceability requirements, and authorized deviation documentation. Operating across product release, sterilization verification, inventory accuracy, and process improvement projects, the Quality Assurance Associate directly supports the operational teams dependent on timely and compliant product authorization.

Duties

• Review DHRs for da Vinci systems, instruments, and accessories for compliance to product specifications and traceability requirements, creating certification documents and authorizing product release.
• Review and approve records from sterilization sub-contractors to assure sterility of single-use products.
• Ensure all non-conformances or deviations are properly approved and documented in the DHR.
• Work collaboratively with internal customers to resolve DHR issues in a timely manner.
• Report on workload status regularly within the team and identify issues posing potential risk to team goals.
• Perform inventory transactions and ensure released products are transacted in a timely manner to maintain inventory accuracy.
• Participate in department process improvement projects or other activities as directed by management.

Experience & Qualifications

• 2+ years of operational experience in a Product Quality or certified manufacturing environment (e.g., FDA, ISO, Mil-Spec).
• Understanding of Medical Device QMS and regulatory requirements including ISO 13485 and U.S. FDA 21 CFR 820.
• Exceptional analytical, problem-solving, and root-cause analysis skills.
• General familiarity with spreadsheet, word processing, and email software.
• Excellent verbal and written communication skills.

A key member of the distribution center quality function, the Quality Assurance Associate delivers line, open box, and inventory audits that identify order accuracy errors, packaging deficiencies, and inventory discrepancies, converting audit findings into actionable data for process improvement. Collaborating across DC associates and management, the Quality Assurance Associate drives corrective action, resolves helpdesk tickets related to DC errors, and supports ongoing performance improvement initiatives.

Functions

• Conduct and assist with line, open box, and inventory audits to identify errors in order accuracy, packaging protection, and inventory quantities.
• Track and maintain all pertinent audit finding data to identify patterns and areas for improvement.
• Assist in resolving helpdesk tickets related to DC errors.
• Conduct root cause and corrective action analysis for process improvement.
• Provide actionable recommendations and support for process and performance improvements derived from internal audit observations.
• Proactively communicate with management regarding quality issues, improvement initiatives, and overall performance.
• Work one-on-one with DC associates to drive process improvement and provide necessary feedback.

Requirements

• Prior Quality Assurance experience required.
• Strong computer and operational skills with the ability to quickly solve technical problems.
• Experience with Root Cause Analysis and employee development and training.
• Engaging, optimistic personality with a growth mindset and adaptable, flexible approach.
• Car enthusiast, specifically European cars, preferred.