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QA Documentation Specialist III
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Overview
Job Description
- Review and approve engineering and validation documentation including IQ, OQ, PQ, PPQ, Validation Master Plans, risk assessments, calibration records, and periodic reviews.
- Create, review, and approve SOPs, Change Controls, CAPAs, deviations, forms, and reports.
- Ensure all documentation complies with corporate procedures, cGMP, and regulatory expectations.
Validation Lifecycle Support:
- Support all phases of the validation lifecycle from design through operation, improvements, and revalidation.
- Participate in commissioning and qualification activities for new installations and systems, ensuring documentation meets cGMP and validation requirements.
- Provide QA oversight for computerized system validation, equipment qualification, utilities, automation, and laboratory instruments.
Cross Functional Collaboration:
- Represent QA in multidisciplinary teams for facility build, laboratory moves, and validation projects.
- Collaborate with Manufacturing, Packaging, Engineering, MSAT, PD, and QA/QC to resolve process issues and implement changes.
- Work with internal and external engineering resources to ensure validation and compliance expectations are met.
Risk Management & Issue Resolution:
- Identify, analyze, and manage risks throughout the product and equipment lifecycle using appropriate risk management tools.
- Assist in investigations and review deviation reports related to equipment, utilities, automation, computer systems, validation, and lab instruments.
- Support continuous improvement of GMP validation and change control programs.
Audit & Compliance Support:
- Participate in internal, client, and regulatory audits.
- Maintain the site in a constant state of inspection readiness.
- Support site management in ensuring cGMP compliance across all operational areas.
Quality Metrics & Governance:
- Establish, maintain, and report Quality KPIs and metrics.
- Participate in Management Review, Quality Review Board, Deviation Review Board, and Change Review Board.
- Perform additional tasks as assigned by the Senior Manager of QA Operations.
Requirements:
- Bachelor's degree in Life Sciences, Engineering, Pharmaceutical Sciences, or a related field (preferred).
- Additional training or certification in Quality Assurance, Validation, or cGMP is an advantage.
- 3 7 years of experience in Quality Assurance, Validation, or related roles within pharmaceutical, biotech, or regulated manufacturing environments.
- Strong understanding of cGMP, validation lifecycle, commissioning/qualification, and quality systems.
- Experience reviewing and approving validation protocols, change controls, deviations, and CAPAs.
- Familiarity with equipment qualification, utilities, automation systems, and computerized system validation.
- Experience supporting audits and maintaining inspection readiness.
- Strong communication, documentation, and cross functional collaboration skills.
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