GMP QA Compliance Specialist

Spectraforce Technologies, Inc.

Westborough (MA)

On-site

USD 65,000 - 90,000

Full time

2 days ago
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Job summary

Spectraforce Technologies, Inc. is seeking a Compliance Specialist to support QA activities for GMP and non-GMP manufacturing programs and Regulatory Submissions at AIRM in Westborough, MA. This 6-month contract emphasizes data integrity, quality, and compliance across QA areas.

Required qualifications include a BS/BA in Life Sciences, Engineering, or Chemistry with 2–3 years of QA GMP experience, or 1–2 years with a Master’s degree, and strong MS Office skills (Excel, PowerPoint).

Qualifications

  • BS/BA in Life Sciences, Engineering, or Chemistry with 2–3 years QA experience in GMP-regulated industry, or 1–2 years with Masters degree.
  • Working fluency in the Microsoft Office productivity suite (Excel, PowerPoint).

Responsibilities

  • Performs QA review of development studies for regulatory submissions, including draft batch records and analytical test records.
  • Ensures developmental studies comply with approved protocols and regulatory guidelines.
  • Identifies and reports documentation errors and deviations from protocols and specifications.
  • Communicates QA review, audit results and reporting to stakeholders.
  • Collaborates with cross-functional teams to address quality events with clear, evidence-backed records.

Skills

MS Office
Excel
PowerPoint
QA Principles

Education

BS/BA in Life Sciences, Engineering, or Chemistry
Masters degree

Job description

Spectraforce Technologies, Inc. is seeking a Compliance Specialist to support QA activities for GMP and non-GMP manufacturing programs and Regulatory Submissions at AIRM in Westborough, MA. This 6-month contract emphasizes data integrity, quality, and compliance across QA areas.

Required qualifications include a BS/BA in Life Sciences, Engineering, or Chemistry with 2–3 years of QA GMP experience, or 1–2 years with a Master’s degree, and strong MS Office skills (Excel, PowerPoint).

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