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QA Documentation Specialist

PublishedPublished: 6/14/2022
Technology

Job Description

Job Description

QA Documentation Specialist

Location: San Diego, CA
Type: Contract
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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