Position located in Andover, MA

Responsibilities of the Quality Control Specialist:

• Participate cGMP activities.
• Provides input on SOPs and client questions.
• Maintain laboratory equipment and supplies as directed.
• Review protocols, testing, reports, and CoA/CoTs for release and stability of AAV based gene therapy products generated at CMOs.
• Monitor, compile, and review analytical and QC data individually and with team members.
• Assist broader Analytical Development/Quality Control team with coordination of sample pulls, set downs, and tracking critical reagents.
• Enter project hours promptly and update project status on appropriate tracking and/or timekeeping systems.
• Assists with writing technical documentation such as OOS, atypical investigations, deviations and CAPAs.
• Assists with writings standard operating procedures (SOPs), methods, qualification protocols and other standard documents as directed.

Requirements of the Quality Control Specialist:

• BS or MS degree in molecular biology, cell biology or virology with at least 2-5 years relevant experience.
• Working experience in a cGMP environment is preferred.
• A strong understanding of cell culture methods, PCR, agarose gel electrophoresis, SDS-PAGE electrophoresis, ELISA, and spectrophotometric assays.
• A familiarity with compendial (USP, ICH, EP) requirements is highly desired.
• Experience in general laboratory experimentation, documentation with adherence to cGMP is necessary.
• Experience in developing, validating, and deploying molecular biology test methods is useful.