Sr QA Reviewer, Biologics Approval

Thermo Fisher Scientific•Foster City, CA

3d•$85,000 - $94,000•Onsite

About The Position

The Senior QA Reviewer provides quality assurance lifecycle support for analytical testing activities, primarily overseeing method transfers, qualifications, validations, investigations, and risk assessments conducted by external partners. The role independently reviews technical documentation, challenges scientific rationale when appropriate, and supports GMP quality operations for biologics analytical testing. It is fully onsite at a customer site in Foster City, California. Applicants from anywhere in the United States are welcome, 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. The position supports analytical testing across the biologics product lifecycle, from cell bank through drug product. It works with external laboratories and internal QC, Manufacturing, and cross-functional teams to ensure compliance with cGMP, ICH, and internal quality standards; assess analytical risks; resolve quality issues; and support product quality decisions. The reviewer also supports regulatory inspections, audits, and responses to observations as needed, while maintaining working knowledge of FDA, Health Canada, ICH, and global GMP requirements relevant to biologics analytical testing. The role is primarily a reviewer within Veeva Vault. The work environment is a laboratory setting and may include exposure to potentially hazardous elements, including infectious agents. The role requires communicating with diverse groups, working upright and stationary and/or standing during typical working hours, lifting and moving objects up to 25 pounds, using standard office equipment and technology, and managing multiple activities under pressure.

Requirements

Bachelor's degree in a laboratory science such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology, or a similar field, with comparable knowledge, skills, and abilities from 4 or more years of experience; alternatively, a master's degree and 2 or more years of related experience.
At least 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 and ability to critically review technical documentation.
Ability to challenge technical counterparts when scientific rationale is unclear or potential compliance or quality concerns are identified.
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.
Ability to communicate, receive, and understand information and ideas with diverse groups in a comprehensible and reasonable manner.
Ability to work upright and stationary and/or standing for typical working hours.
Ability to lift and move objects up to 25 pounds.
Ability to use and learn standard office equipment and technology proficiently.
Ability to perform successfully under pressure while prioritizing and handling multiple projects or activities.
Legal authorization to work in the United States without sponsorship.
Ability to pass a comprehensive background check, including drug screening.

Nice To Haves

Experience with Veeva Vault is preferred.
Experience working within document review workflows, including offline review processes, is beneficial.
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, to ensure 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 support risk assessments 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 decisions are 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.
Annual incentive plan bonus and potential 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 (PTO).
10 paid holidays annually.
Paid parental leave, including 3 weeks for bonding and 8 weeks for caregiver leave.
Accident and life insurance.
Short- and long-term disability in accordance with company policy.
Competitive 401(k) U.S. retirement savings plan.
Employee Stock Purchase Plan (ESPP), which gives eligible colleagues the opportunity to purchase company stock at a discount.
Career and development prospects.