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Quality - Document Coordinator

Job in Harvard, Worcester County, Massachusetts, 01451, USA
Listing for: TechDigital Group
Full Time position
Listed on 2026-10-23
Job specializations:
  • Quality Assurance - QA/QC
    QA Specialist - Analyst/Manager, Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 55000 - 75000 USD Yearly USD 55000.00 75000.00 YEAR
Job Description & How to Apply Below

Job Description:

Must have:

  • Experience in MS Office (Word, Excel, PowerPoint, etc.)
  • Experience with Document Management systems, either manual or electronic. Electronic preferred.
  • Experience archiving controlled / critical records.
  • Experience in a regulated environment (Manufacturing, Food Industry, Medical Device, etc.)

Responsibilities:

  • Manages and executes the initiation, processing, routing, distribution, and archiving of cGMP documentation.
  • Manages the document change control process, coordinating cross-functional reviews, approvals, and effective dates in alignment with requirements (cGMP and Client) and customer needs.
  • Serves as a subject matter expert for the electronic document management system.
  • May assist in user training on the electronic document management system.
  • Provides Records Management support during regulatory agency inspections and corporate audits.
  • Education and skills:

    • Minimum HS diploma with related experience required. A B.S. degree (in Science, Engineering, or Biochemistry) is preferred.
    • A minimum of 2 years of relevant experience including at least 1 year of direct document management experience in a regulated environment focused on product quality.
    • Strong teamwork and communication skills and the ability to follow written and verbal instructions.
    • Knowledge of biotech bulk and finished product manufacturing, and analytical testing is highly desirable.
    • Familiarity with US and EU cGMP regulations and guidance is required.
    • Working knowledge of common computer systems such as MS Word and Excel is required.
    • Experience with electronic document management systems is preferred.
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