Quality Control Analyst- Biotechnology

A biotechnology client is looking for a Senior Quality Control Reviewer , specifically with documentation experience in biotechnology or pharmaceutical industry

Primary Responsibilities Include:

• Assist broader Analytical Development/Quality Control team with coordination of sample pulls, set downs, and tracking critical reagents.
• Monitor, compile, and review analytical and QC data individually and with team members.
• Trend data for qualified materials, release products, and stability products.
• Assist with Freezer works (Sample Management inventory system), Sample submission and receiving paperwork, and support shipping of critical material (DOT/IATA training to be provided).
• Create and maintain clear, concise records and documentation.
• Review protocols, raw data packets, reports, and CoA/CoTs for release and stability of AAV based gene therapy products (e.g., qPCR, cell-based assays, ELISA, SDS-PAGE, HPLC, MS, and Western Blot) generated at CTLs/CMOs, and internally at Sarepta.
• Perform other related duties incidental to the work described.

Desired Education and Skills:

• A basic understanding of cell culture methods, polymerase chain reaction (PCR,) agarose gel electrophoresis, SDS-PAGE electrophoresis, ELISA, and spectrophotometric assays.
• Operate as part of a team, assisting associates in providing a functional, safe working environment while maximizing laboratory efficiency.
• Associate or B.S degree in Biology, Chemistry, or related field with at least 1 year of relevant experience in an industry setting required.
• Working experience in a cGMP environment is preferred.
• Must have effective written and verbal communication skills.
• Experience in general laboratory experimentation, documentation with adherence to cGMP is necessary.