Quality Assurance Inspector – III

SGS_JOB_3469

Business Support
 Massachusetts
GMP Investigations
Deviation Management
OOS/OOT Review
cGMP Compliance
QA Oversight
Written Communication
Cross-Functional Collaboration
Vault QMS

Contract - 01 Year (Contract with potential to extend)

Location (mandatory): 1 Burtt Road, Andover, MA 01810 The QA Investigation Reviewer independently reviews and approves GMP investigations at the Andover biopharma manufacturing facility, ensuring compliance with cGMP regulations, site, and global procedures while supporting product quality, patient safety, and timely batch disposition.

Job Responsibilities:

  • Independently review and approve GMP investigations within the Andover biopharma manufacturing facility.
  • Ensure non-conformances/deviations, OOS/OOTs, and other quality events are thoroughly investigated and compliant with cGMP regulations, site, and global procedures.
  • Support product quality, patient safety, and timely batch disposition.
  • Partner with cross-functional teams including Manufacturing, Engineering, and Quality Control.
  • Provide objective QA oversight and support during regulatory inspections and audits.

Skills:

  • Strong critical thinking and analytical abilities.
  • Clear and effective written communication.
  • Objective QA oversight and inspection readiness.
  • Experience with quality systems; Vault QMS experience is a plus.

Education/Experience:

  • High school diploma or GED required; associate or bachelor’s degree preferred.
  • 5–7 years of experience in quality assurance or inspection roles.

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