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QA Documentation Specialist III
Katalyst Healthcares & Life Sciences • Tampa, FL, US • published 2026-09-29 02:55:16.066629
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**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:** **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, improvemen...
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