Quality Control Analyst - Astrix : Job Details

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.