Job Information
FUJIFILM DIOSYNTH BIOTECHNOLOGIES Quality Assurance in COLLEGE STATION, Texas
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QA Supervisor - Day Shift
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Job LocationsUS-TX-College Station
Posted Date
3 hours ago
(12/11/2024 12:07 PM)
Requisition ID : 2024-32798
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) Operations Supervisor, will be responsible for the overall performance of the QA group. The supervisor will handle all associated responsibilities in compliance with Fujifilm quality policies and site SOPs to ensure regulatory compliance.
Reports to
Senior Manager, Quality Assurance
Work Location
College Station, TX
Primary Responsibilities:
Supervise and provide direction to direct reports.
Serve as TrackWise Administrator.
Monitor and support site and global quality policies and procedures to ensure GMP compliance.
Work with QA management to design and implement quality assurance training programs for staff development.
Provide cGMP guidance to operations, QC and QA.
Lead client audits and regulatory inspections.
Utilize investigative techniques to determine root causes of deviations and proper corrective and preventative actions.
Develop, motivate and lead direct reports towards achieving organizational and individual goals.
Conduct periodic staff meetings.
Review and/or approve basic and technical documentation 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
