Sr Specialist, Quality Assurance
On-siteCollege Station, Texas, United States
Job Summary
Review and approve commissioning, qualification, and validation protocols, reports, and discrepancies for Quality Assurance in compliance with local, global, and regulatory standards. Collaborate with site functions to instill a Quality Culture by coaching on GMP principles, while managing the QA Validation Monthly Tracker and supporting client due diligence and regulatory inspections. Utilize investigative techniques to determine root causes of discrepancies, coordinate daily with Validation and Engineering teams, and promptly notify Senior Management of potential quality or regulatory issues. Work in a biomanufacturing facility in College Station, Texas, requiring flexibility for weekends, off-shifts, and occasional travel.
Required Qualifications
- Master's degree preferably in a science-related field with at least three (3) years of related experience, including Operational Quality of Compliance Engineering roles
- Bachelor's degree preferably in a science-related field with at least five (5) years of related experience, including Operational Quality of Compliance Engineering roles
- Associate's degree preferably in a science-related field with at least seven (7) years of related experience, including Operational Quality of Compliance Engineering roles
- At least three (3) years of cGMP experience or other highly regulated industry
- Experience with qualification/validation of process equipment, clean utilities, automation, sterile filling, aseptic processing, facilities, HVAC, and new construction final qualification requirements of TOP's for GMP facilities
- Must have a working knowledge of cGMP regulations for the production of drug, biologics or vaccine products
- Must be willing to work flexible hours
- Ability to work weekends and off-shift hours, as needed to support manufacturing activities
- Must be willing to travel occasionally, as needed
- Attendance is mandatory
Desired Qualifications
- Degree in Engineering or other Science related i.e. Biology, Chemistry or Biotechnology
- Facility Validation, QC, Biotech equipment experience is a plus
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