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QA Specialist (GMP)

South Waltham, MA 02453

Posted: 07/09/2024 Employment Type: Direct Hire Industry: Quality Job Number: 9792 Pay Range: $80,000-$100,000 Department: Life Science Job Setting:

Job Description

Responsibilities:
  • May be required to assist with activities associated with equipment, instrument, utilities, and/or facility qualification activities including change control, and support of site programs.
  • Provide QA support of change controls, GMP investigations and CAPAs.
  • Participate in compliance walkthroughs and help drive the closure of any audit observations.
  • Generation, review and maintenance of Quality System documentation and procedures.
  • Provision of suggestions and comments, evaluation and approval of changes directly related to the critical systems, manufacture and analytical methods.
  • Review of standard operating procedures.
  • Review of  GMP related documents, such as specifications, methods, validation documents, technology transfer documents, etc.


Requirements:
  • BS degree in Biology, Chemistry, or related area.
  • Must have 3+ years Quality Assurance in a GMP environment.
  • Experience providing QA support and oversight of GMP manufacturing operation including equipment/ facilities qualification, utilities and batch release.

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Commonwealth Sciences
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About South Waltham, MA

Ready to take the next step in your career journey? Explore job opportunities in the vibrant area of South Waltham, Massachusetts! This historic town nestled in Middlesex County offers a perfect blend of modern amenities and scenic landscapes. With easy access to renowned institutions like the Charles River Museum of Industry and Innovation, the Rose Art Museum, and the Gore Place, South Waltham provides a rich cultural experience for residents and visitors alike. Enjoy a stroll along the Charles River Reservation or catch a game at the iconic Fenway Park. Delight your taste buds with a diverse culinary scene that includes local favorites like clam chowder and lobster rolls. Embrace the charm of South Waltham and uncover rewarding career prospects in this thriving community.