2013…..NOW HIRING….GMP QA Associate…..Ardea Biosciences/Astra Zeneca
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 seeking an Associate Director, Analytical Sciences to join its’ dynamic team.
The successful candidate will assure cGMP compliance with applicable regulatory requirements including audits and documentation review.
Interested parties please apply today at: www.ardeabio.com/careers or submit your resumes to: firstname.lastname@example.org
No third party recruiters please.
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.