Quality Assurance Specialist

Company: Randstad USA
Location: Berkeley
Posted on: January 13, 2022

Job Description:

Job SummaryThis department supports final inspection of product vials and packaged material to ensure products are free of defects and meets specifications. Review and approve finished product batches and manufacturing records using scientific principles. Release raw material received on Berkeley site.Job Responsibilities

• Review and approve API/finished product batch and manufacturing records using scientific principles.
• Prepare and release Raw Material used at Berkeley site
• Perform final inspection of product vials and packaged material to ensure products are free of defects and meets specifications.
• Determine acceptability or rejection of vial/packaged product and take necessary steps to remediate potential issues (e.g., halting the production process).
• Represent QA in interactions with Manufacturing, QA, QC, Supply Chain and Regulatory inspections.
• Enter, review and query data in electronic systems (e.g., BASICS, Dev@com, LIMS) to support lot release activities.
• Write and revise SOP's;
• Review and approve of specific area documentation (e.g., change control, deviation) using scientific principles as needed.Education & Qualifications
  • Bachelor's degree in a Science or Technical field (minimum education required; Include degree and concentration)
  • At least six years of experience in the biopharmaceutical, has general knowledge of the techniques used in other disciplines in the QC department and has a general understanding of how results from each discipline impact the quality of the drug substances manufactured

Keywords: Randstad USA, Berkeley , Quality Assurance Specialist, Other , Berkeley, California