QA Associate LOC : San Diego ,CA

QA Associate LOC : San Diego ,CA

  • Posted on : 09-08-2023
  • Job Type : Full Time only
  • Salary : 100,000 - 200,000

Job Description:

Responsibilities:

  • Reviews production batch records and associated data for product release.
  • Determines if records are within range of cGMP regulations.
  • Reviews data obtained for compliance specifications and report abnormalities.
  • Evaluates the impact of deviations and adverse events to product quality.
  • Interacts with clients and follows up on client inquiries.
  • Conducts cGMP audits including audit preparation, execution of the audit, the audit report, and follow up to any findings.
  • Assists in the writing of detailed reports and analyzes quality data.Creates, revises, and reviews SOPs including compliance documentation initiation, revisions, and deletions.
  • Ensures completeness and accuracy of information contained in all documents, document files, databases, and documentation systems.
  • Ensures completeness and accuracy of information contained in all documents, document files, databases, and documentation systems.
  • Performs logbook documentation audits for cGMP regulated logs and SOPs.
  • Performs Line Clearances for cGMP processes.Creates cGMP labels, and reviews and reconciles cGMP label generation.
  • Embodies clients cultural values and aligns daily actions with department goals and company culture.
Requirements:

  • High School Diploma or equivalent. Bachelos degree strongly preferred in a Life Sciences discipline or equivalent.
  • Minimum four (4) years of relevant experience in documentation review, QA or equivalent exposure.
  • Minimum one (1) year of batch review experience.
  • Working knowledge of GLP and cGMP regulations 21 CFR Part 11, 210, 211, 600 & EU guidelines and good documentation practices.
  • Experience in investigations writing and review preferred.
  • Knowledge of Fill Finish and Biologics production environments strongly preferred.Detail oriented with strong written and verbal communication skills.
  • Ability to work independently, within prescribed guidelines, or as a team member.


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