What are the responsibilities and job description for the Senior Quality Assurance Associate position at Meet Life Sciences?
Job Title: Senior Associate, Quality Assurance
Location: Bothell, WA (Onsite)
Schedule: 4-day, 10-hour shifts (Wed–Sat or Sun–Wed)
Summary:
The Senior Associate, Quality Assurance is responsible for performing routine QA activities that support ongoing manufacturing operations at a clinical and commercial manufacturing facility. This onsite role provides direct QA oversight, batch record review, raw material disposition, and support for investigations, change controls, and continuous improvement efforts.
Key Responsibilities
- Review and approve executed electronic batch records, comments, and discrepancies.
- Review test results and perform LIMS review steps to issue Certificates of Analysis (as applicable).
- Provide QA support on the manufacturing floor, including cleanroom operations.
- Act as a QA point of contact for escalations, troubleshooting, and process support.
- Perform hands-on QA activities such as patient apheresis intake and drug product pack-out.
- Compile, review, and approve lot disposition documentation.
- Conduct raw material disposition and approve raw material specifications.
- Review and approve Deviations, CAPAs, Change Controls, Excursions, and Nonconformance records.
- Support process/method qualifications and validation activities through QA review of protocols, data, and reports.
- Participate in internal audits and operational excellence initiatives.
- Promote a strong culture of safety, compliance, and continuous improvement.
Qualifications
- BS degree in a relevant scientific field (biochemistry, bioengineering, chemical engineering, etc.) with 7 years of industry experience.
- 4–6 years in GMP biopharmaceutical operations, including 2 years in GMP Quality.
- Experience with electronic quality management systems (deviations, CAPAs, change controls).
- Experience in clinical and cGMP manufacturing environments.
- Familiarity with cellular therapy and/or lentiviral vector manufacturing preferred.
- Strong analytical, communication, and cross-functional collaboration skills.
- Ability to prioritize, meet deadlines, and adapt in a fast-paced, start-up environment.
- Proficiency with digital GMP platforms.