Quality Analyst Jobs

About The Position

Requirements

• Minimum of a Bachelor's degree in Chemistry, Engineering, Life Sciences, or a related discipline.
• 5+ years of experience in Quality Assurance experience within the pharmaceutical or biotechnology industry, preferably supporting Quality Control operations.
• Experience supporting Gene Therapy and/or biologics experience, a must.
• Strong knowledge of cGMP regulations and global laboratory compliance standards (FDA, EMA, ICH).
• Experience with deviations, investigations, CAPAs, change controls, and method validation oversight.
• Working knowledge of data integrity principles and regulatory expectations, including electronic records and laboratory systems compliance.
• Familiarity with risk management tools (e.g., FMEA) and risk-based decision-making.
• Solid understanding of QC laboratory operations and analytical testing.
• Familiarity with analytical techniques such as HPLC/UPLC, CE-SDS, Cell Based Potency Assay, ddPCR, ELISA, Microbiology safety assay and related methodologies.
• Experience with quality and laboratory systems (e.g., Veeva, LIMS, Chromeleon, BMRAM or equivalent).
• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint, Outlook).
• Strong analytical thinking and sound judgment.
• Highly organized with strong attention to detail, accuracy, and clarity.

Responsibilities

• Provide QA oversight of internal and external QC laboratory operations to ensure compliance with cGMP regulations and global health authority requirements.
• Serve as the QA point of contact for assigned products, stability programs, and/or laboratory functions.
• Review and approve release and stability analytical testing documentation, raw material qualifications, method validation protocols and reports, and equipment qualification documentation.
• Review and approve SOPs, deviations, investigations, CAPAs, change controls, and supplier notifications.
• Provide QA oversight of OOS, OOT, and atypical laboratory investigations to ensure scientifically sound root cause analysis and compliant documentation.
• Assess quality impact of laboratory events and escalate high-risk, cross-functional, or potentially regulatory-impacting issues to QA management as appropriate.
• Review and approve equipment qualification, calibration and maintenance program.
• Ensure compliance with data integrity requirements, including 21 CFR Part 11 and Annex 11.
• Ensure analytical methods and documentation remain aligned with regulatory filings and current product registrations.
• Track record status and analyze laboratory metrics and analytical trends to support compliance and continuous improvement.
• Review and approve internal and external analytical method qualification/validation.
• Participate in cross-functional discussions to provide quality input and risk-based recommendations.
• Support internal and external audits, regulatory inspections, and supplier-related quality activities as needed.
• Partner with QC to drive continuous improvement initiatives and maintain audit readiness.

Benefits

• Comprehensive medical, dental, and vision coverage
• Mental health support
• Annual wellbeing reimbursement
• Access to our Employee Assistance Program (EAP)
• Generous paid time off policies
• Fertility and family-forming benefits
• Caregiver support
• Flexible work schedules with purposeful in-person collaboration
• 401(k) plan with a competitive company match
• Annual equity awards
• Participation in our Employee Stock Purchase Plan (ESPP)
• Company-paid life and disability insurance
• Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
• Employee resource groups
• Service and recognition programs
• Meaningful opportunities to connect, volunteer, and give back