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QA Document Control Specialist

Company: Planet Pharma
Location: Chelsea
Posted on: June 9, 2021

Job Description:

The Quality Document Control Specialist is responsible for performing multiple activities in support of Quality Assurance department and its clients. Supports the management of controlled documents via the implemented document control system.

  • Essential Duties and Responsibilities include the following.
  • Facilitates the full life cycle of master documents (including but not limited to SOPs, Batch Records, Test Methods, Protocols, Reports, Specifications, etc.).
  • Reviews, edits, formats master documents according to approved procedures and templates, maintains document properties (metadata), monitors document status and approval notifications, distributions and archiving.
  • Interacts with internal customers to provide customer service for document formatting, routing, issuance, copying, scanning, etc.
  • Facilitates the archival of GMP documentation and records.
  • Prepares and inspects documents for scanning operations, scans and re-assembles documents
  • Coordinates the transfer of records to / from long term storage facilities; manages records classifications and storage location in the Record Management System (RMS).
  • Ensures records are maintained according to regulatory requirements.
  • Supports document retrieval for internal and external audits.

Education or Equivalent:

  • 1 year of relevant work experience in the Biotechnology or Pharmaceutical industries or relevant comparable background preferred.


  • Excellent oral and written communication skills.
  • Exhibits strong attention to detail.
  • Strong organizational skills required.
  • Displays an emerging ability to manage client expectations.
  • Ability to manage both day-to-day operations as well as project work in a fast paced environment.

Knowledge/Skills Requirements:

Must be proficient in MS Office Suite.

Physical Requirements:

Requires physical activity such as standing for long periods of time, walking, bending, and working with hands.


Keywords: Planet Pharma, Chelsea , QA Document Control Specialist, Other , Chelsea, Massachusetts

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