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Randstad, Marietta, PA (20.87 miles from 17109)
temporary $ 25.00 - $ 25.00 per hour
This position will provide compliance assurance through the review of records to include batch documentation, training records, calibration records, standard operating procedures, regulatory policies, testing and manufacturing specifications, validation documents, and other technical documents; leading investigations, initiating deviations and determining corrective action. As a member of the Value Stream Packaging & Logistics team, be co-responsible for the site and the department results. Ensure personal objectives are aligned with site goals and objectives. Working hours: TBD -Up to 18 month contracted position - B.S or B.A in a technical discipline, preferably Microbiology, Biology/Virology, Biochemistry, Chemistry or Pharmacy. Degree in other discipline if sufficient technical depth has been achieved from professional experience. - Minimum of 3 years pharmaceutical experience investigating manufacturing deviations either in a QA or manufacturing role; preferrably in Biologics Secondary Manufacturing . - Working knowledge of pharmaceutical facilities, equipment and systems. Including a technical understanding of industry and science practices related to the business in order to apply knowledge to daily activities. - Demonstrated problem solving and investigational skills. - Knowledge of GMP's, NIH Guidelines, FDA and other regulatory agency requirements sufficient to apply to quality operations and compliance. Preferred Requirements: Relevant to the role, but not critical/essential - Lean and Six Sigma knowledge - User experience with SAP is highly preferred. - Work experience with parenteral dosage forms (aseptically filled vials, syringes); biologics is highly preferred - Biologics Secondary Manufacturing . Randstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad. [show more]
- June 25, 2015
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