The QA Validation Specialist will be responsible for the review and approval of commissioning/qualification/validation protocols, reports, and discrepancies for Quality Assurance. The QA Validation Specialist will handle all associated responsibilities in compliance with Fujifilm quality policies and site SOPs to ensure regulatory compliance.
Reports to QA Specialist I, QA Validation
Work Location College Station, TX
Primary Responsibilities:
- Provides QA direction to the validation team during document review to ensure the organization is complying with local and global quality standards, regulatory requirements, and partner commitments.
- Work collaboratively with other site functions to instill a ‘Quality Culture’ by coaching in the application of GMP Principles including the underlying rational of those principles.
- Support client due diligence and Quality audits as well as regulatory inspections.
- Reviews and approves master plans, pre/post approval of qualification and validation protocols, summary reports, and associated data for conformance to regulations, SOPs, specifications, and other applicable acceptance criteria.
- Reviews and approves qualification and validation deviations and discrepancies, supports investigations and corrective actions.
- Participate in design reviews and have experience in reading P&ID’s and various engineering drawings.
- Coordinate with Validation, Metrology, Facilities, Engineering, on a daily basis to ensure any GMP protocols, requirements etc. are completed in a timely manner.
- Utilize investigative techniques to determine root causes of discrepancies and proper corrective and preventative actions.
- Promptly notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
- Perform other duties and projects as assigned and required.
Qualifications:
- Bachelor’s degree in a related science concentration with some experience in Quality Assurance supporting pharmaceutical or biotechnology products; OR
- Associate’s degree in a related science concentration with 2+ years of experience in Quality Assurance supporting pharmaceutical or biotechnology products; OR
- High School Diploma or GED with 4+ years of experience in Quality Assurance supporting pharmaceutical or biotechnology products.
- Knowledge of GMP/GLP regulations preferred.
- Degree in Biology, Chemistry or Engineering preferred.
- Role model for company core values of trust, delighting our customers, Gemba, and Genki.
