Senior Documentation Specialist for Pharmaceutical Projects

4 days ago


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

Job Title: Senior Documentation Specialist for Pharmaceutical Projects

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Location: Canton, MA

Contract Type: 6 Month Contract (Potential Extensions)

Estimated Salary: $60,000 - $80,000 per year

The QS Senior Documentation Specialist supports the documentation activities in support of product production and release. This role involves a great deal of interaction with various departments, including Production, Purchasing, Materials, Quality Assurance, Quality Control, Regulatory, and Logistics.

Main Responsibilities:

  • Perform SmartSolve Document Management routing, review, and approval activities. Issue training packets as needed.
  • Maintain databases for Document Control room inventory.
  • Control and maintain Device Master Records, Equipment History Files, and Process Flow Diagrams.
  • Responsible for filing and maintaining archived documents.
  • Assist with the destruction of documents outside the required retention period and/or preparation of records for storage offsite.
  • Ensure records are maintained, secure, and retrievable throughout defined record retention periods.
  • Review Facilities documentation for compliance prior to filing in the Equipment History Files.
  • 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 required.
  • 3-5 years of related experience in a GMP/GLP regulated environment.
  • Documentation experience required.

About Beacon Hill Life Sciences - Boston:

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

We offer competitive compensation and benefits packages to our employees. If you are passionate about your work and looking for a challenging opportunity, please submit your application.



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