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QA Specialist

Jamaica Plain, MA 02135

Posted: 07/19/2024 Employment Type: Direct Hire Industry: Quality Job Number: 9812 Pay Range: $90,000-$100,000/yr Department: Life Science Job Setting:

Job Description

Responsibilities:
  • Responsible for batch disposition activities. Review batch data, including batch records, deviations, in-process data, EM data, QC release testing and other quality systems as applicable to determine acceptability of product disposition.
  • Provide production floor support and provide guidance for GMP product quality and compliance for product release, including resolution of product quality investigations and quality issues of a significant nature, and provides direction for product disposition decisions including shipment.
  • Review and approval of manufacturing documents.
  • Develop and deliver technical training programs
  • Support drafting and revising Quality Agreements between CMOs/Suppliers 
  • Provide QA support of change controls, GMP investigations and CAPAs. OOS and OOT investigations and ensuring appropriate CAP actions are identified.

Requirements:
  • BA/BS degree and 3+ years QA experience in a regulated GMP environment
  • Demonstrated success by independently leading cross-functional teams
  • Experience providing QA support and oversight of GMP manufacturing operation including batch release
 

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About Jamaica Plain, MA

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