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 Senior GLP QA Associate to join it's dynamic team.
The successful candidate will assure GLP compliance with applicable regulatory requirements including audits, training programs and documentation review. Strong knowledge of GLP bioanalytical and dose analysis is required.
Primary Duties and Responsibilities
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- Represents and interfaces with multiple departments and external providers to provide Good Laboratory Practices guidance in an effective manner.
- Develops, revises, and reviews Standard Operating Procedures.
- 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.
- Maintain QA CRO files.
- Trouble-shoots and takes the initiative on any QA-related issue for GLP compliance.
- Performs QA In-Study audits to ensures completeness and accuracy of information contained in all study documentation.
- Maintains the GLP archives; and participates in the implementation and maintenance of the document management system.
- Reviews protocols, study reports, and ensures that no deviations from approved protocols were made without proper authorization/documentation were performed in accordance with the GLP guidelines.
- Carry out job responsibilities and assignments safely and maintain a clean and safe work area.
- Other duties as may be necessary.
- Bachelor's (BS) in the Life Sciences or related discipline.
- At least six to eight years' demonstrated experience in the GLP responsibilities listed above.
- Strong knowledge of GLP regulations and good documentation practices.
- Strong writing skills in protocols, SOPs and QA reports.
- Strong knowledge of GLP bioanalytical and dose analysis.
- Must have ability to listen, communicate effectively (both orally and in writing) and to interact with all levels within the organization. Excellent reasoning, interpersonal and organizational skills, and superior attention to detail.
- Extensive skills, knowledge and abilities with computers and software programs including Word, Excel, and document management programs.
- High attention to detail, and the ability to work in a fast-paced and team environment.
Alcock & McFadden - 13 months ago