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GMP QA Associate

Ardea Biosciences, Inc.

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Location: San Diego, CA Posted Date: 5/1/2013 Position Type: Full time Job Code: 234 Required Education: Bachelors Degree Areas of Expertise Desired: Quality Assurance

Description

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.

Requirements

•   Bachelor’s (BS) or higher in the Life Sciences or related discipline.
•   At least two to four years’ experience demonstrated experience in the QA responsibilities listed above.
•   Strong knowledge of GMP regulations and good documentation practices.
•   Strong writing skills in protocols, SOPs and QA reports.
•   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.

Apply online today at: www.ardeabio.com/careers
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