Demo

Document Control Specialist

Master Compliance
Andover, MA Full Time
POSTED ON 2/17/2025
AVAILABLE BEFORE 5/14/2025

Role : GxP Document Control Senior Specialist

Location : Andover, MA (Hybrid - 3 Days Onsite)

Duration : 3 Months (With high possibility of Extension)

Rate : Competitive - Only USC or GC on W2 or 1099

Position Overview :

One of my Customer is seeking a detail-oriented and highly organized GxP Document Control Sr. Specialist (Contractor) to support our Quality Control (QC) and compliance functions. This role is responsible for managing both physical and electronic GxP documentation in alignment with Good Documentation Practices (GDP) and regulatory requirements. The ideal candidate will have experience in document control within a regulated environment, a strong understanding of archival processes, and the ability to ensure data integrity across records.

Key Responsibilities :

  • Co-manage the Andover Archive Room, overseeing the issuance, tracking, reconciliation, and archival of paper GxP records to maintain compliance and accessibility.
  • Issue paper laboratory notebooks to QC personnel, ensuring accurate tracking and documentation.
  • Process and review controlled electronic documentation within Client’s electronic Quality Management System (eQMS) in accordance with internal procedures and regulatory requirements.
  • Perform true copy verification reviews of published electronic records, ensuring accuracy and compliance with GDP and data integrity standards.
  • Assist in advanced formatting of document content and templates to maintain consistency and compliance across documentation.

Qualifications :

  • Experience : 10 – 15 years experience in GxP document control, quality assurance, or a related role within the biotech, pharmaceutical, or life sciences industry.
  • Regulatory Knowledge : Strong understanding of GxP requirements, Good Documentation Practices (GDP), and data integrity principles.
  • Technical Skills : Proficiency with electronic Quality Management Systems (eQMS) and Microsoft Office Suite (Word, Excel, PowerPoint).
  • Attention to Detail : Ability to meticulously review, track, and manage documentation with a focus on compliance.
  • Organizational Skills : Strong ability to manage multiple tasks, prioritize effectively, and work in a fast-paced environment.
  • Collaboration : Ability to work cross-functionally with QC, QA, and other stakeholders to ensure documentation integrity and compliance.
  • Experience utilizing an EDMS - Preferably Veeva Quality Docs
  • Managing, tracking and archiving records
  • Preferred Qualifications :

  • Prior experience with true copy verification processes.
  • Familiarity with document control in a biotech, pharmaceutical, or GMP-regulated environment.
  • Experience formatting and managing controlled documents and templates.
  • This contract position offers an exciting opportunity to contribute to Client’s mission while ensuring the highest standards of GxP documentation compliance. If you are a highly motivated professional with a passion for quality and precision, we encourage you to apply!

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