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.