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 a GLP QA Associate to join it's dynamic team.
The GLP QA Associate will assure GLP compliance with applicable regulatory requirements, protocols, analysis plans, SOPs and methods during protocol reviews, in-process inspections, data review and reporting phase audits.
Primary Duties and Responsibilities
Represents and interfaces with multiple departments to provide Good Laboratory Practices guidance in an effective manner.
Performs internal GLP audits and or assists in the coordination of audits from outside parties.
Addresses, resolves and mediates corrective actions in audit findings and prepares written reports as necessary; ensures training of internal staff as appropriate.
Trouble-shoots and takes the initiative on any QA-related issue for GLP compliance.
Performs QA In-Study (In-Process) audits at adequate intervals to ensure completeness and accuracy of information contained in all study documentation; notifies the study director and management immediately of any problems found during the course of an inspection that may affect study integrity.
Participates in the implementation and maintenance of the document management system.
Reviews protocols, sample analysis plans, SOPs, raw data, methods and study reports; ensures that no deviations from approved requirements were made without proper authorization/documentation and were performed in accordance with the GLP guidelines.
Provides a signed statement for inclusion in final study reports specifying dates inspections were made and findings reported to management and the study director.
Carries out job responsibilities and assignments safely and maintains a clean and safe work area.
Performs other duties as may be necessary.