QC Supervisor, Cell Biology - Second Shift

Job Title

QC Supervisor, Cell Biology

Job Description

Reports to QC Manager, Cell Biology

Work Location College Station, TX

Primary Responsibilities :

• Supervise and lead the QC Cell Biology / Immunology Staff, including hiring, supervision, coaching, mentoring, discipline, and performing annual review assessments.
• Coordinate QC testing for GMP release and stability testing.
• Ensure QC equipment is maintained in a qualified state.
• Prepares and executes tech transfer, qualification and validation protocols and reports as needed.
• Writes, revises, and reviews Standard Operating Procedures (SOPs) and other Good Manufacturing Practices (GMP) documentation.
• Establish a system for managing test samples, reagents and reference standards.
• Critical reagent / system suitability qualification and management.
• Review and approve data / reports during release & stability testing.
• Ensures laboratory compliance to established specifications and procedures.
• Reports excursion / out of specifications results and conducts investigations as needed.
• Assure the implementation of appropriate and timely corrective actions.
• Work closely with Quality Assurance and other departments to continuously improve the effectiveness of the Quality Management team.
• Follow all established laboratory, regulatory, safety, and environmental procedures.
• Identify deviations and report possible preventative and corrective actions.
• Perform other duties as assigned.

Qualifications :

Physical Requirements :

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).