Documentation Specialist

5 days ago


Canton, Ohio, United States Beacon Hill Life Sciences - Boston Full time
Job Description

Beacon Hill Life Sciences - Boston is seeking a skilled Documentation Specialist to join their team.

This is a 6 Month Contract opportunity with potential extensions.

The successful candidate will support the documentation activities in support of product production and release, interacting with various departments including Production, Purchasing, Materials, Quality Assurance, Quality Control, Regulatory, and Logistics.

The primary responsibilities include:

  • Performing SmartSolve Document Management routing, review, and approval activities, and issuing training packets as needed.
  • Maintaining databases for Document Control room inventory.
  • Controlling and maintaining Device Master Records, Equipment History Files, and Process Flow Diagrams.
  • Filing and maintaining archived documents.
  • Assisting with the destruction of documents outside of the required retention period and preparing records for storage offsite.
  • Ensuring records are maintained, secure, and retrievable throughout defined record retention periods.
  • Reviewing Facilities documentation for compliance prior to filing in the Equipment History Files.
  • Communicating areas of deficiency to responsible individuals.
  • Maintaining 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.

Beacon Hill Life Sciences - Boston is an Equal Opportunity Employer that values diversity in the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.


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