Quality Assurance Engineering Manager

Commonwealth Sciences, Inc.
North Quincy, MA
Closing date
Sep 26, 2021

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Pharmaceutical, Quality Assurance
Position located in Newton, MA.

Responsibilities of the Quality Assurance Engineering Manager:
  • Provide leadership and oversight to QMS groups to ensure that projects are completed in a timely and effective manner.
  • Participate in building/improving and maintaining quality systems that are compliant with all applicable regulations and standards moving from clinical to commercial development.
  • Create, implement and maintain SOPs, policies and procedures consistent with corporate and quality objectives.
  • Perform routine reviews on manufacturing batch records and the associated analytical data and documents in support of product disposition in accordance with specifications and SOPs.
  • Perform method, process, equipment, and cleaning qualification/ validation documentation review/approval.
  • Other tasks as assigned by Departmental Management.

Requirements of the Quality Assurance Engineering Manager:
  • BA/BS in life science or engineering related discipline with 2+ years QA experience in a biotech, pharmaceutical, or medical device environment
  • Experience creating or scaling up Quality Management Systems
  • Familiarity with FDA, ISO regulations or cGMP guidelines
  • Proficient in Microsoft word and other QMS related software

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