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Quality Assurance Specialist

Boston Metro Area, MA

Post Date: 04/07/2017 Job ID: JN -042017-18780 Job Type: Quality Assurance - Scientific
Description:
Duties:

Mission
  • Member of a Quality Assurance group (contract basis) providing quality and compliance support for aspects of process development and commercial manufacturing of drug substance/drug product.
  • Support internal and external Quality Systems and Operations, such as facility/equipment, materials and production.
  • Assure compliance with current GMPs.
Key duties:
  • Review/Approve of Batch Records (including APS, Engineering and Development runs) and other related documentation.
  • General documentation review to support other departments as needed (e.g. reports, Forms, solution records, etc.)
  • Shop floor support as needed (Quality Oversight, logbook review, solve issues real time with operations personnel, etc.)
  • SOP/reports generation, review and/or approval
  • Experience as an investigator (preferred but not required)
Scope and dimensions
  • Incumbents activities have impact on all GxP-related departments for marketed products manufactured within the Canton and Contract facilities.
  • Work effectively and efficiently in a cross functional team environment
  • Maintain the QA relationship(s) with other departments to assure complete and accurate exchange of information, resolution of issues, and timely completion of assigned activities.
  • Prepare, review and approve controlled documents relevant to GxP operations
Skills:
  • Incumbents activities have impact on all GxP-related departments for marketed products manufactured within the Canton and Contract facilities.
  • Work effectively and efficiently in a cross functional team environment
  • Maintain the QA relationship(s) with other departments to assure complete and accurate exchange of information, resolution of issues, and timely completion of assigned activities.
  • Prepare, review and approve controlled documents relevant to GxP operations
Education:
  • Minimum of a B.S. in Biology, Chemistry, Microbiology or related field
Experience:
  • Must have a minimum 3-5 years of relevant experience within Quality or Compliance
  • Must have previous biologics, biotechnology, pharmaceutical or biopharmaceutical experience.
  • Industry experience with aseptic operations preferred

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