QA Documentation Specialist

GenoviceSan Diego, CA
Onsite

About The Position

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

  • 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.

Nice To Haves

  • Experience with document-control or electronic quality-management systems is preferred.

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.
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