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2017-01-29 05:19:36
Responsibilities:
Key Skills:
QA Associate LOC : San Diego ,CA
2017-01-29 05:19:36
Job Type:
Full Time only
Budget $: 100,000 - 200,000
Budget $: 100,000 - 200,000
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.
- 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.
Key Skills:
