Develops, revises, formats, and reviews GMP master batch records and manufacturing documentation. Collaborates with Quality, Manufacturing, and technical experts to gather information, ensure compliance with GMP and site procedures, manage document revisions and approvals, maintain version control, identify documentation gaps, and support corrections. Requires pharmaceutical or life-sciences batch-record experience, technical writing and editing skills, and familiarity with document-control or electronic quality-management systems.
QA Documentation Specialist
Location: San Diego, CA
Type: Full Time
Industry: Pharmaceutical Manufacturing
Position Overview
Our client is seeking a QA Documentation Specialist to support the development, revision, and review of GMP manufacturing documentation. The ideal candidate will have pharmaceutical or life-sciences experience and a strong understanding of how to create and assemble clear, compliant batch records.
Requirements
Key Responsibilities
- Create, revise, format, and review master batch records and related manufacturing documents.
- Work with Quality, Manufacturing, and technical subject-matter experts to collect required information.
- Ensure documents comply with GMP, good documentation practices, and site procedures.
- Manage document revisions, approvals, and version control.
- Identify documentation gaps and support corrections.
Qualifications
- Experience developing or reviewing batch records in a pharmaceutical, biotech, or life-sciences environment.
- Working knowledge of GMP and good documentation practices.
- Strong technical writing, editing, formatting, and organizational skills.
- Experience with document-control or electronic quality-management systems is preferred.
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