Document Control Specialist

1 day ago

Piscataway, New Jersey, United States Astrix Full time

We are seeking a Document Control Specialist for our client who has a global footprint in both R&D and manufacturing within the biopharma industry. The Document Control Specialist is responsible for managing and maintaining the company's controlled documentation system to ensure compliance with regulatory requirements, internal quality standards, and current Good Manufacturing Practices (cGMP). This individual will oversee document lifecycle activities including creation, revision, review, approval, issuance, archival, and retrieval of controlled documents to support quality systems and operations within a biotechnology environment.

Type:
Contract-to-hire

Shift:
M-F, 1st Shift

Location:
Middlesex County, NJ

Key Responsibilities

  • Administer the document control system, ensuring documents are properly formatted, reviewed, approved, issued, and archived according to internal procedures.
  • Maintain and update Standard Operating Procedures (SOPs), Forms, Work Instructions, Protocols, and Reports in compliance with cGMP and company standards.
  • Manage document change requests, coordinate reviews and approvals, and ensure timely implementation of revisions.
  • Support training coordination by ensuring current versions of controlled documents are available and distributed appropriately.
  • Track document status, version history, and effective dates using electronic or manual tracking systems.
  • Ensure compliance with 21 CFR Part 210/211, Part 11, and other relevant regulatory requirements.
  • Support internal and external audits by retrieving controlled documents and records as requested.
  • Assist with Quality System activities such as CAPA, change control, and deviations, as needed.
  • Participate in continuous improvement initiatives to streamline document control and quality processes.

Qualifications

  • 2–5 years of experience in Quality Assurance, Quality Systems, or Document Control within the biotechnology, biopharmaceutical, or pharmaceutical industry.
  • Strong understanding of GMP, GDP (Good Documentation Practices), and FDA/ICH guidelines.
  • Experience with electronic document management systems (EDMS) such as Veeva Vault, MasterControl, or similar platforms preferred.
  • Excellent attention to detail, organizational, and communication skills.
  • Ability to manage multiple priorities and deadlines in a fast-paced, regulated environment.
  • Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook)

*This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you

INDBH*

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