QA Documentation Specialist
Intellectt INC
Job Title: QA Documentation Specialist
Location: New Hampshire Seacoast
Employment Type: Contract W2
Duration: 8 Months
Experience: 3 5+ Years
Pay Rate: $40 $43/hr W2 (DOE)
About the Role
We are seeking an experienced QA Documentation Specialist to support GMP Quality Assurance operations. The ideal candidate will have strong experience reviewing, approving, and maintaining controlled documentation related to validation, qualification, equipment, instrumentation, computerized systems, and analytical systems within a regulated environment.
Responsibilities
- Review and approve GMP-controlled documents, including SOPs, protocols, reports, specifications, and quality records.
- Review validation and qualification documentation for equipment, instrumentation, computerized systems, and analytical systems.
- Ensure documentation complies with GMP, quality procedures, regulatory requirements, and documentation standards.
- Identify documentation gaps, discrepancies, and compliance issues and work with cross-functional teams to resolve them.
- Support audit and inspection readiness by ensuring quality records are accurate, complete, traceable, and properly maintained.
- Collaborate with QA, Validation, Engineering, Laboratory, Manufacturing, and other functional teams.
Required Qualifications
- 3 5+ years of experience in QA Documentation, Quality Assurance, or a related GMP environment.
- Strong experience with GMP documentation review and approval.
- Experience reviewing validation and qualification records.
- Experience with equipment/instrumentation and computerized or analytical systems documentation.
- Strong understanding of GMP, quality systems, document control, and regulatory compliance.
- Excellent attention to detail, organization, and written communication skills.
Preferred Qualifications
- Experience in pharmaceutical, biotechnology, or life sciences manufacturing.
- Familiarity with CSV/CSA, IQ/OQ/PQ, validation protocols/reports, and quality systems.
- Experience supporting FDA inspections or audit readiness.
Vacancy posted 2 days ago
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