QA Document Control Specialist
Company: Planet Pharma
Posted on: June 9, 2021
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
- 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
- Interacts with internal customers to provide customer service
for document formatting, routing, issuance, copying, scanning,
- 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
- Supports document retrieval for internal and external
Education or Equivalent:
- 1 year of relevant work experience in the Biotechnology or
Pharmaceutical industries or relevant comparable background
- Excellent oral and written communication skills.
- Exhibits strong attention to detail.
- Strong organizational skills required.
- Displays an emerging ability to manage client
- Ability to manage both day-to-day operations as well as project
work in a fast paced environment.
Must be proficient in MS Office Suite.
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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