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.
We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to
Human Resources Request Form. The EEOC "Know Your Rights" Poster is available
here.
To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy:
https://insightglobal.com/workforce-privacy-policy/ .
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
Experience supporting quality systems and regulatory submissions or documentation
Veeva experience
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.