QA Supervisor, Operations

Quality Assurance Supervisor

The Quality Assurance (QA) 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.

The work we do at FUJIFILM Biotechnologies Texas has never been more importantand we are looking for passionate, mission-driven people who want to make a real difference in people's lives. From developing the next vaccine to advancing cell and gene therapies, we collaborate with industry leaders to tackle complex challenges and deliver meaningful solutions.

If you're ready to help transform the future of medicine, join FUJIFILM Biotechnologies. We offer a flexible work environment and we're proud to cultivate a culture that will fuel your passion, energy, and drivewhat we call Genki. Our state-of-the-art biomanufacturing facility is located in College Station, Texas, which combines a small-town feel with vibrant culture, top-notch schools, and close proximity to big city life. Nestled between major hubs, it's a dynamic location that blends convenience with innovation.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles."

Job Description

Reports to Senior Manager, Quality Assurance

Work Location College Station, TX

Essential Functions :

• 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
• Manage Internal 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
• Identify process and Quality System improvement opportunities.
• Promptly notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
• Assist with compliance related functions.
• Work as a team member; be cooperative with all departments and staff to meet company objectives.
• All other duties as assigned.

Required Skills & Abilities :

Working Conditions & Physical Requirements :

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to :

Qualifications :

Preferred Qualifications :

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBTHR@fujifilm.com or (979) 431-3500).