GMP Document Control & Records Specialist

Tunnell Consulting; Boston (MA); On-site; USD 55,000 - 76,000; Part time

Job summary

Tunnell Consulting is seeking a Document Control Specialist for a contract role based in the greater Boston area. The position focuses on administering GMP documentation, ensuring accuracy, and maintaining controlled records throughout their lifecycle.

Work is onsite for a 3-month project at ~24 hours per week, with 40–55 USD per hour based on experience, and collaboration with QA, Manufacturing, and support teams. Local candidates only; prior GMP-regulated experience is preferred.

Qualifications

• High School Diploma or GED required.
• Associate’s or Bachelor’s degree preferred.
• 1-3 years of document control, records management, administrative, or pharmaceutical experience preferred.
• Experience in a GMP-regulated environment is a plus.

Responsibilities

• Issue, track, and reconcile controlled paper documents.
• Review documents for completeness, accuracy, and proper formatting.
• Maintain document logs, archives, and filing systems.
• Distribute controlled copies of SOPs, forms, batch records, and other GMP documents.
• Retrieve and archive documents according to retention requirements.
• Ensure obsolete documents are removed from circulation and properly archived.
• Support document revisions, approvals, and document change activities.
• Assist with audits and inspections by locating and providing requested documentation.
• Maintain confidentiality and security of controlled records.
• Collaborate with Quality Assurance, Manufacturing, and other departments to support documentation needs.

Job description

Tunnell Consulting is seeking a Document Control Specialist for a contract role based in the greater Boston area. The position focuses on administering GMP documentation, ensuring accuracy, and maintaining controlled records throughout their lifecycle.

Work is onsite for a 3-month project at ~24 hours per week, with 40–55 USD per hour based on experience, and collaboration with QA, Manufacturing, and support teams. Local candidates only; prior GMP-regulated experience is preferred.