12 Month Contract to Hire
Required Skills & Experience
2+ years experience in document control or administrative support, preferably in a regulated pharmaceutical or biotech environment
Familiarity with GxP regulations and document control best practices
Experience with Electronic Document Management systems (EDMS)
Committed to working on-site 4 days weekly
Nice to Have Skills & Experience
Experience supporting quality systems and regulatory submissions or documentation
Veeva experience
Job Description
We are seeking a detail-oriented and highly organized Document Control Coordinator to join our team in a fast-paced pharmaceutical environment. This role is critical in supporting the document control function to ensure compliance with regulatory requirements and internal quality standards. The ideal candidate will have experience in document management systems (DMS), strong administrative skills, and a commitment to maintaining data integrity and confidentiality.
Key Responsibilities:
Maintain and manage controlled documents in accordance with company SOPs and regulatory guidelines (e.g., FDA, EMA, ICH).
Support the creation, revision, formatting, issuance, and archival of controlled documents such as SOPs, batch records, protocols, and reports.
Ensure timely routing and tracking of documents for review and approval using electronic document management systems (EDMS).
Assist in preparing documentation for audits and inspections.
Maintain document logs, trackers, and databases to ensure accurate and up-to-date records.
Coordinate document training assignments and maintain training records.
Provide administrative support to the Quality Assurance and Regulatory Affairs teams as needed.
Collaborate with cross-functional teams to ensure document compliance and accessibility.
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