Quality Control Supervisor - Cell Biology

The Quality Control Cell Biology Supervisor will be responsible for coordinating the installation and qualification of new analytical equipment in support of GMP release and stability testing.  The Cell Biology/Immunology Supervisor will lead tech transfer activities of qualified cell based and immunological methods from designated donor laboratories.  The Supervisor will play a pivotal role in selecting qualified personnel to staff the QC Cell Biology laboratory.   

External US

Essential Functions:

• 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.

Required Skills & Abilities:

• Sound understanding and knowledge of ELISA based methods including potency and colorimetric assays.
• Operate as a team leader, coordinate staff scheduling.
• Ability to follow safety procedures outlined in the Chemical Hygiene Plan.
• Utilize MSDS sheets to properly assess chemical hazards, spill response procedures, and PPE requirements if indicated.
• Develop staff to maximize contributions to team and company.
• Ability to multi-task and prioritize work assignments with little supervision.
• Excellent attention to detail.
• Computer proficiency required.
• Ability to accurately review and complete required documentation.
• Excellent written and oral communication skills.
• Excellent organization and analytical skills.

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:

• Experience prolonged standing, some bending, stooping, and stretching.
• Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
• Ability to sit for long periods to work on a computer.
• Potential for exposure to hazardous chemicals, gases, fumes, odors, mists, and dusts, and other hazardous materials.
• Ability to wear personal protective equipment including safety glasses, lab coat, and gloves.
• Attendance is mandatory.

Minimum Qualifications:

• Ph.D. preferably in Biology, Biochemistry, or a related scientific discipline with at least three (3) years' industry experience in a GMP / GxP or a comparable federally regulated environment of which two (2) years are in a supervisory or lead role; OR  
• Master's degree preferably in Biology, Biochemistry, or a related scientific discipline with at least six (6) years' industry experience in a GMP / GxP or a comparable federally regulated environment of which two (2) years are in a supervisory or lead role; OR  
• Bachelor's degree preferably in Biology, Biochemistry, or a related scientific discipline with at least seven (7) years' industry experience in a GMP / GxP or a comparable federally regulated environment of which two (2) years are in a supervisory or lead role.  

Preferred Qualifications:

• Hands on laboratory and supervisory experience in a GLP/GMP regulated environment is preferred.

We are an equal opportunity and affirmative action employer.  All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law. 

If an accommodation to the application process is needed, please e-mail FDBTHR@fujifilm.com or call 979-431-3500.