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Sterling Life Sciences, Specialists in Pharmaceuticals, Healthcare and BioTech Recruitment
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 Job #02874 Email this job to a friend
About our client
Our client operates a network of state-of-the-art facilities across North America. They have a proven record for flexible service and accurate results. Their Bioanalytical Department is operated with high-tech equipment, with fully integrated software and automated sample handle processing.
Position Location
Quality Assurance Manager Texas
Salary
Highly competitive package, commensurate with experience
Responsibilities
1) Perform audits to ensure compliance with written company procedures, study protocols and applicable regulations
2) Plan, design and execute audits of bioanalytical studies
3) Prepare audit reports
4) Review and interpret regulations affecting bioanalytical research
5) Participate in developing quality improvement strategies
Requirements
1) Bachelor’s degree in a health-related field (advanced degree in Pharmaceutical Sciences preferred)
2) Experience and current knowledge of the FDA guidelines and GLP
3) Auditing experience in a regulatory environment (bioanalytical audits)
4) Familiarity with applying statistical sampling strategies
5) Familiarity with analytical instrumentation, including ability to critically evaluate chromatograms
6) Superb interpersonal and analytical reasoning skills
7) Good problem-solving skills
8) Computer literacy (Microsoft applications)

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