QA Documentation Specialist III

• 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.