Ardea Biosciences, a wholly owned subsidiary of AstraZeneca, is headquartered in San Diego, CA. We are a biotechnology company focused on the development of small-molecule therapeutics for the treatment of serious diseases.
Ardea is searching for a GMP QA Associate to join the team.
The successful candidate will assure cGMP compliance with applicable regulatory requirements including audits and documentation review.
Primary Duties and Responsibilities
• Represents and interfaces with Pharmaceutical Sciences and Regulatory Affairs to provide Good Manufacturing Practices guidance in an effective manner.
• Reviews production batch records and associated data for product release; determines if records are within range of cGMP regulations.
• Reviews Analytical Certificate of Analysis data packages for compliance with approved methods.
• Archive and file QA documents.
• Maintain vendor files and track and trend vendor deviation/out of specification and non-conformance events.
• Develops, revises and reviews Standard Operating Procedures.
• Reviews equipment calibration and qualification documents to ensure compliance with internal procedures and manufacturer performance specifications.
• Trouble-shoots and takes the initiative on any QA-related issue for GMP compliance.
• Reviews protocols, study reports, etc. for product release and method validation; ensures that no deviations from approved protocols were made without proper authorization/documentation were performed in accordance with the GMP guidelines.
• Carry out job responsibilities and assignments safely and maintain a clean and safe work area.
• Other duties as may be necessary.