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.