Sr. QC Reviewer
Boston, MA (Onsite)
Job Description:
Primary Responsibilities Include:
- Review protocols, test reports, and Certificates of Analysis/Compliance (CoA/CoT) for the release and stability testing of AAV-based gene therapy products (e.g., qPCR, ddPCR, in-vitro assays, ELISA, SDS-PAGE, HPLC, MS, and Western Blot) conducted at Contract Testing Labs (CTLs), Contract Manufacturing Organizations (CMOs), and internally.
- Compile, monitor, and review analytical and quality control data, both independently and collaboratively with team members.
- Assist the Analytical Development/Quality Control team in coordinating sample pulls, set downs, and tracking of critical reagents.
- Maintain accurate and thorough records and documentation.
- Support method development, transfer, and qualification/validation activities for the release of bacterial plasmids, viral vectors, critical reagents, and reference materials.
- Conduct a percentage of lab work weekly, as required by review priorities.
- Trend data for qualified materials, released products, and stability programs.
- Assist in drafting and reviewing quality documentation such as SOPs, OOS/OOT reports, CAPAs, and Change Controls.
- Serve as a liaison with CMOs, coordinating method development, transfer, and stability testing at various CMO/CRO sites.
- Author and review test methods, development reports, study protocols, and validation reports.
- Perform other related duties as required.
- Strong experience on cell culture techniques, PCR, agarose gel electrophoresis, SDS-PAGE, ELISA, and spectrophotometric assays.
- Familiarity with compendial guidance (USP, ICH, EP) is a must.
- Experience in laboratory work, documentation, and adherence to cGMP is required.
- Must have experience with developing, validating, and implementing molecular biology test methods.
Desired Education and Skills:
- Bachelor’s or Master’s degree in molecular biology, cell biology, or virology with 5-8 years of relevant experience.
- Experience in a cGMP environment is preferred.
