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Km80.5

QA Manager - DR/CAPA

Delta Project Management

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Location: Peninsula/Redwood City, CA Posted Date: 4/13/2013 Position Type: Consultant, Contract Job Code: DPM ZoHo 49 Required Education: Bachelors Degree Areas of Expertise Desired: Quality Assurance

Description

Evaluate and approve deviations and CAPA. Respond to deviations with corrective and preventive actions that will prevent recurrence and result in deviation reduction. Partner effectively with Manufacturing and QC to meet deviation and release deadlines.

Requirements

BS or BA, preferably in a scientific discipline, and a minimum of 5 years experience in the pharmaceutical, biologics, medical device, or related GMP regulated industry. Also requires: * working knowledge of the biopharmaceutical process * ability to assess, investigate, and resolve deviations * strong ability to plan and prioritize complex and conflicting objectives to meet goals * strong ability to work with cross functional peers to achieve goals * excellent people skills to convince, motivate, and encourage partners to accept recommendations * strong written and oral communication skills * strong critical thinking skills * intermediate computer skills - Word, Excel * strong attention to detail * familiarity with QC assays and processes a plus * prior experience at the Emeryville site a plus
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