Location: Durham NC
Schedule: Monday–Friday, 8:00 AM – 5:00 PM
Pay Rate: $30–$40/hour (W2)
Contract Duration: 3 months (with potential for extension)

We are seeking a Specialist I, Document Control & Records Management to support the site’s documentation and record-keeping systems in accordance with cGMP and regulatory requirements. This role ensures controlled documents—including SOPs, batch records, and quality forms—are properly created, maintained, archived, and retrievable to support compliance across manufacturing, quality, and operations.

The ideal candidate will work cross-functionally with Manufacturing, Quality, Engineering, and other departments to maintain documentation standards and support audits, process improvements, and system training.

• Administer the document control and records management systems in compliance with FDA, EMA, ICH, and cGMP guidelines.

• Process controlled documents through their lifecycle: creation, revision, approval, issuance, distribution, and archival.

• Ensure all documents follow current formatting, content, and template standards.

• Issue and reconcile batch production records and logbooks; maintain accurate archiving (electronic and physical).

• Support document retrieval and record review during internal and external audits/inspections.

• Facilitate periodic reviews to ensure documents remain current and effective.

• Provide user support and basic training on document control systems (e.g., Veeva Vault, MasterControl, TrackWise, Documentum).

• Identify opportunities for continuous improvement in document and records processes.

• May assist with related quality system processes (e.g., Change Control, CAPA, Training).

• Bachelor’s degree in a scientific, technical, or related field preferred; equivalent work experience considered.

• Minimum 3 years of experience in document control or records management in a cGMP-regulated pharmaceutical, biotech, or medical device environment.

• Proficient with electronic document management systems (e.g., Veeva Vault, MasterControl, Documentum).

• Strong attention to detail and understanding of cGMP documentation best practices.

• Effective communication and collaboration skills across departments.

• Comfortable working in a fast-paced, regulated environment.

• Proficient in Microsoft Office (Word, Excel, PowerPoint).

• Prior experience supporting sterile or aseptic manufacturing.

• Experience issuing and archiving executed batch records and logbooks.