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Cambridge, Massachusetts

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Quality Engineer
Collaborate with site operations and quality control personnel to deliver active pharmaceutical ingredients and pharmaceutical excipients meeting appropriate quality guidance.  The quality engineer is accountable for compliance of GMP processes with ICH Q7, IPEC and other applicable quality standards.   Responsibilities: Perform product release for GMP manufactured product in accordance with ICH Q7 and/or IPEC requirements. Disposition off grade and returned GMP manufactured product. Maintain procedures pertinent to GMP manufacturing. Design and deliver GMP training to site associates. Investigate customer complaints, manufacturing deviations, off grade production for GMP manufactured product.


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