Our biopharmaceutical client in Piscataway is seeking a Quality Control Analyst to join their team. This position is responsible for analytical testing and data verification in a GMP-regulated laboratory.
Pay: $30-35/hr
Location: Piscataway, NJ
Job Type: Contract-Hire
Key Responsibilities:
- Analytical testing to support product in-process, release, Raw materials and stability programs.
- Strong knowledge of cGMP, Quality Systems, and ICH / regulatory guidance.
- Conduct, compile, and/or review Out of Specification lab investigations, deviations, and corrective and preventative actions plans.
- Work with cross-functional teams to advance projects, maintain equipment, and authoring documents and reports.
- Performs other functions as required or assigned
- Complies with all company policies and standards
- Perform the investigation analysis during the non-conformance.
- Conduct the investigation process as a part of Quality Event and work with supervisor to close the investigation.
Education/Experience:
- Bachelor's degree in biotechnology, biochemistry, chemistry, or related field with 3-5 years of experience in a pharmaceutical/biotech QC laboratory.
- Demonstrated success working with techniques such as HPLC, SDS-PAGE, cell-based bioassays, capillary electrophoresis, SDS-PAGE, ELISA, and standard compendial assays.
- Familiarity with preparing regulatory dossiers and data packages for interactions between regulatory agencies.
- Strong background in small molecule and protein chemistry and experience troubleshooting analytical results.
- Demonstrated success at writing, revising, and complying with SOPs, policies, and QC methods.