What are the responsibilities and job description for the QA Documentation Specialist III position at Katalyst CRO?
Job Description
The QA Engineer is responsible for ensuring timely development, review, and approval of engineering, validation, and lifecycle documentation in alignment with corporate procedures, SOPs, cGMP, and industry best practices. This role supports manufacturing, engineering, validation, and quality teams by providing oversight across the full validation lifecycle, ensuring inspection readiness, and maintaining a compliant state for all equipment, utilities, systems, and processes. The QA Engineer plays a key role in supporting new installations, change controls, deviations, CAPAs, and continuous improvement initiatives.
Responsibilities
The QA Engineer is responsible for ensuring timely development, review, and approval of engineering, validation, and lifecycle documentation in alignment with corporate procedures, SOPs, cGMP, and industry best practices. This role supports manufacturing, engineering, validation, and quality teams by providing oversight across the full validation lifecycle, ensuring inspection readiness, and maintaining a compliant state for all equipment, utilities, systems, and processes. The QA Engineer plays a key role in supporting new installations, change controls, deviations, CAPAs, and continuous improvement initiatives.
Responsibilities
- Quality Review & Documentation Oversight:
- 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.
- 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.
- 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.
- 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.
- 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.
- 37 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 crossfunctional collaboration skills.