Kloudhire

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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