Job Information
FUJIFILM DIOSYNTH BIOTECHNOLOGIES Quality Assurance Analyst (QA Analyst) III in College Station, Texas
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QA Analyst III - All Shifts
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Job LocationsUS-TX-College Station
Posted Date
2 weeks ago
(12/18/2024 7:26 PM)
Requisition ID : 2024-32892
Category : Quality Assurance
Company (Portal Searching) : FUJIFILM Diosynth Biotechnologies
Overview
The work we do at FDB has never been more importantand we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in peoples lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what FDB call Genki.
External US
College Station, Texas may be a small, university town, but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of small-town life and the convenience of living close to the vibrant pulse of big cities. Eighty-seven percent of Texas' population lives within a 180-mile radius, so we are in the center of it all in Texas. And our site is nestled in the hub of innovation, representing a source of pride for the area.
The Quality Assurance (QA) Analyst III, under minimal direction, will be responsible for review and/or approval of basic and technical documentation, drafting and reviewing of internal Quality policies and procedures, performing product related activities, performing Quality audit functions, performing product release activities, identifying process and Quality System improvements, and acting as a QA liaison internally and externally.
Reports to
Director, Quality Assurance/Senior Manager, Quality Assurance
Work Location
College Station, TX(On-site at NCTM building)
Primary Responsibilities:
Review and/or approve basic and technical documentation with minimal supervisory oversight to include, but not limited to:
- Standard Operating Procedures
- Batch Production Records (completed and approval)
- Commissioning, qualification and validation protocols and reports
- Deviation Reports
- Corrective Action/Preventive Action Plans
- Technical data review and approval
- QC data review and approval
- Drug Substance/Product Reports
- Trending QA data
Draft and review internal Quality policies, procedures, and reports.
Perform inspection of final product containers and review and/or approval of executed process records and data.
Perform Quality audit functions to include, but not limited to:
- Audit of lab notebooks
- Audit of equipment logbooks
- Review of vendor, supplier, contract laboratory audit questionnaires
- Lead vendor, supplier, contract laboratory and client audits