Sr QA Reviewer, Biologics Approval

Thermo Fisher Scientific • Foster City, CA

1d • Onsite

About The Position

The Senior QA Reviewer provides quality assurance lifecycle support for analytical testing activities in biologics, with a primary focus on oversight of method transfers, qualifications, validations, investigations, and risk assessments conducted by external partners. The role requires a compliance-driven QA professional who can independently review technical documentation, challenge scientific rationale when appropriate, and support GMP quality operations.

The position supports analytical testing across the biologics product lifecycle, from cell bank through drug product, and provides oversight of external laboratories and analytical method lifecycle activities. The reviewer works with QC, Manufacturing, and cross-functional teams to assess analytical risks, resolve quality issues, support product quality decisions, and develop remediation strategies. The role also includes reviewing GMP documentation and supporting regulatory inspections, audits, and responses to observations as needed.

This is a fully onsite role at a customer site in Foster City, California, with a standard Monday–Friday work schedule. Applicants from anywhere in the United States may apply, but relocation assistance is not provided. Candidates must be legally authorized to work in the United States without sponsorship and pass a comprehensive background check, including drug screening.

Requirements

• Bachelor’s degree in a laboratory science such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology, or a similar discipline, plus comparable experience of 4 or more years; alternatively, a master’s degree and 2 or more years of related experience.
• Minimum of 4 years of relevant QA experience.
• Strong background in Analytical Quality Assurance or Analytical Development QA.
• Experience providing QA oversight for GMP QC operations.
• Biologics industry experience, including Drug Substance, Drug Product, or Cell Bank activities.
• Experience reviewing documentation generated by external contract laboratories or testing organizations.
• Strong GMP and compliance focus.
• Ability to critically review technical documentation and challenge technical counterparts when scientific rationale is unclear or quality or compliance concerns arise.
• Independent thinking and sound quality judgment.
• Highly organized, able to manage fluctuating workloads, and able to work independently with minimal direction.
• Excellent verbal and written communication skills.
• Proactive identification and escalation of quality concerns.
• Able to communicate, receive, and understand information and ideas with diverse groups in a comprehensible and reasonable manner.
• Able to work upright and stationary and/or standing for typical working hours.
• Able to lift and move objects up to 25 pounds.
• Able to work in non-traditional work environments and use and learn standard office equipment and technology proficiently.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
• Legally authorized to work in the United States without sponsorship and able to pass a comprehensive background check, including drug screening.

Nice To Haves

• Experience with Veeva Vault; the role will primarily function as a reviewer within Veeva Vault.
• Experience with document review workflows, including offline review processes.
• An equivalent combination of appropriate education, training, and/or directly related experience may be considered sufficient to meet the role requirements.

Responsibilities

• Provide QA support and oversight for analytical testing activities across the biologics product lifecycle, from cell bank through drug product.
• Oversee external laboratories and analytical method lifecycle activities, including qualification, verification, and validation, for compliance with cGMP, ICH, and internal quality standards.
• Review and support approval of analytical methods, protocols, reports, and laboratory investigations, including deviations, OOS, and OOT events.
• Partner with QC, Manufacturing, and cross-functional teams to assess analytical risks, resolve quality issues, and support product quality decisions.
• Apply Quality Risk Management principles to analytical and quality systems activities and ensure appropriate documentation and compliance.
• Evaluate documentation generated by external testing partners.
• Review laboratory investigations resulting from routine testing events.
• Assess root cause analyses and investigation conclusions.
• Provide QA feedback and recommendations.
• Partner with QC leadership to develop remediation and path-forward strategies.
• Review risk assessments associated with method transfers, validations, and related quality events.
• Ensure risk-based decision-making is scientifically justified and compliant.
• Review GMP documentation, including procedures, risk assessments, analytical methods, protocols, and reports.
• Assist with regulatory inspections, audits, and responses to observations as needed.
• Maintain working knowledge of FDA, Health Canada, ICH, and global GMP requirements relevant to biologics analytical testing.

Benefits

• Competitive remuneration and eligibility for a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy.
• Choice of national medical and dental plans and a national vision plan, including health incentive programs.
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement.
• At least 120 hours of paid time off and 10 paid holidays annually.
• Paid parental leave, including 3 weeks for bonding and 8 weeks for caregiver leave.
• Accident and life insurance, and short- and long-term disability in accordance with company policy.
• Competitive 401(k) U.S. retirement savings plan.
• Employees’ Stock Purchase Plan offering eligible colleagues the opportunity to purchase company stock at a discount.
• Career and development prospects.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior