Job Description

Title: GxP Doc Control Sr Specialist

Location: Hybrid Andover – 3 days on-site

Contract End Date: 2 months from the start date, this medical leave could be extended.

Type: W2 contract

Position Overview:

The client 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 the 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 the mission while ensuring

compliance with the highest standards of GxP documentation.

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