QC Supervisor, Chemistry
Fujifilm
- College Station, TX
- Permanent
- Full-time
- Supervise and lead the QC Chemistry Staff, including hiring, supervision, coaching, mentoring, discipline, and performing annual review assessments.
- Coordinate and QC analytical testing for GMP release and stability testing.
- Ensure QC equipment is maintained in a qualified state.
- Prepare and execute tech transfer, qualification and validation protocols and reports as needed.
- Write, revise, and review Standard Operating Procedures (SOPs) and other Good Manufacturing Practices (GMP) documentation.
- Establish a system for managing test samples, reagents, and reference standards.
- 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.
- Work collaboratively with manufacturing and product development teams to improve quality, increase efficiency, solve problems, generate cost savings, and provide new product support.
- Interface with current and potential clients as well as interface with investigators during internal and external inspections.
- Follow all established laboratory, regulatory, safety, and environmental procedures.
- Identify deviations and report possible preventative and corrective actions.
- Perform other duties as assigned.
- Master’s degree preferably in Chemistry or Biochemistry with 3+ years’ industry experience in a GMP/GxP or a comparable federally regulated environment; OR
- Bachelor’s degree preferably in Chemistry or Biochemistry with 5+ years’ industry experience in a GMP/GxP or a comparable federally regulated environment.
- 2+ years are in a lead or supervisory role required.
- Analytical laboratory experience in a GLP/GMP regulated environment is preferred.
- Experience in Trackwise Deviation Management software.
- Experience in Empower 3 software.
- Sound understanding and knowledge of SEC, UPLC, and Capillary Electrophoresis instrumentation and methodologies.
- 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.
- Role model for company core values of trust, delighting our customers, Gemba, and Genki.
- 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.