Quality Control Analyst

job
  • Astrix
Job Summary
Location
Piscataway ,NJ 08854
Job Type
Contract
Visa
Any Valid Visa
Salary
PayRate
Qualification
BCA
Experience
2Years - 10Years
Posted
02 Jan 2025
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Job Description

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.
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