Document Review Specialist

Summary: The Document Review Specialist role is a contract position based in North Carolina, focusing on ensuring compliance with quality documentation standards in a pharmaceutical manufacturing environment. The specialist will be responsible for reviewing and approving test protocols, conducting documentation reviews, and training teams on Good Documentation Practices (GDP). This position offers an exciting opportunity to contribute to a new manufacturing facility as part of a growing organization.

Key Responsibilities:

• Read and understand CQV and site quality procedures, aligning with operating principles and regulatory requirements.
• Work with electronic validation systems such as KNEAT.
• Conduct GDP reviews of test protocols pre and post execution.
• Utilize and maintain a GDP checklist to track errors in protocols and documents.
• Conduct general documentation reviews to ensure GDP requirements and standard formatting are met.
• Liaise with CQV Leads, Engineers, and other departments to resolve GDP errors.
• Train CQV teams on GDP standards.

Key Skills:

• Extensive experience in documentation review and/or Quality Assurance for cGMP Documentation.
• Prior experience in highly regulated industries, particularly in Large Scale Projects or GMP operational facilities.
• Experience liaising with other departments and engineers/QA.
• Strong communication skills and ability to escalate issues.
• Strong knowledge of executing complex projects in a Pharma/cGMP environment.
• Proficient in computer skills (Spreadsheets, Word Processing, Visio, Microsoft Word).

Salary (Rate): undetermined

City: undetermined

Country: United States

Working Arrangements: undetermined

IR35 Status: undetermined

Seniority Level: undetermined

Industry: Other