Documentation Specialist

1 week ago


Sharon, Massachusetts, United States Beacon Hill Full time
Job Title: Documentation Specialist

Location: Sharon, MA

Contract Duration: 6 Months (Potential Extensions)

About the Role:

The Documentation Specialist will support the documentation activities in support of product production and release, interacting with various departments to ensure smooth operations.

Key Responsibilities:

  • Perform SmartSolve Document Management routing, review, and approval activities, ensuring security and easy retrieval of controlled files.
  • Maintain databases for Document Control room inventory and control and maintain Device Master Records, Equipment History Files, and Process Flow Diagrams.
  • Responsible for filing and maintaining archived documents, ensuring records are secure and retrievable throughout defined retention periods.
  • Review Facilities documentation for compliance prior to filing in the Equipment History Files and communicate any areas of deficiency to responsible individuals.
  • Maintain the cell bank database in Excel by entering new binders into inventory and tracking hard copies taken for reference.

Requirements:

  • Associate's Degree or equivalent
  • 3-5 years of related experience in a GMP/GLP regulated environment
  • Documentation experience required

About Beacon Hill:

Beacon Hill is a company that values diversity and promotes equal opportunities for all individuals. We encourage individuals with disabilities and protected veterans to apply.

Equal Opportunity Employer:

Beacon Hill is an equal opportunity employer that values the strength diversity brings to the workplace. Individuals with disabilities and protected veterans are encouraged to apply.



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