cGMP Document Control & Records Specialist

Kelly; Durham (NC); On-site; USD 41,000 - 55,000; Full time

Benefits offered by this job

Retirement savings plan

Holiday pay

Transit spending account

Paid sick leave

Job summary

Kelly is seeking a Specialist I, Document Control & Records Management in Durham, NC to support the site's documentation and record-keeping systems in compliance with cGMP and regulatory requirements.

The role ensures controlled documents, SOPs, batch records, and quality forms are created, maintained, archived, and retrievable to support audits, process improvements, and system training across manufacturing, quality, and operations.

Qualifications

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

Responsibilities

• 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 (Veeva Vault, MasterControl, TrackWise, Documentum).
• Identify opportunities for continuous improvement in document and records processes.
• May assist with related quality system processes (Change Control, CAPA, Training).

Skills

Attention to detail

Cross-functional collaboration

Effective communication

Education

Bachelor’s degree in a scientific, technical, or related field

Tools

Veeva Vault

MasterControl

Documentum

Job description

Kelly is seeking a Specialist I, Document Control & Records Management in Durham, NC to support the site's documentation and record-keeping systems in compliance with cGMP and regulatory requirements.

The role ensures controlled documents, SOPs, batch records, and quality forms are created, maintained, archived, and retrievable to support audits, process improvements, and system training across manufacturing, quality, and operations.