QC Supervisor, Chemistry

Position Overview

The Quality Control Chemistry Supervisor under general supervision will be responsible for planning organizing directing and evaluating routine activities of the QC Chemistry staff as well as coordinating the installation and qualification of new analytical equipment in support of GMP release and stability testing. The Chemistry Supervisor will lead tech transfer activities of qualified analytical methods from a designated donor laboratory. The Chemistry Supervisor will play a pivotal role in selecting qualified personnel to staff the QC chemistry laboratory.

Company Overview

The work we do at FUJIFILM Biotechnologies Texas has never been more importantand we are looking for passionate mission-driven people like you who want to make a real difference in peoples 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 youre ready to help transform the future of medicine join FUJIFILM Biotechnologies. We offer a flexible work environment and were 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 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 its a dynamic location that blends convenience with innovation.

Fujifilm is globally headquartered in Tokyo with over 70000 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. Visit: Description

Reports to QC Manager Chemistry

Work Location College Station TX

Primary Responsibilities:

• Supervise and lead the QC Chemistry Staff including hiring supervision coaching mentoring discipline and performing annual review assessments.
• Coordinate 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.

Required Skills & Abilities:

• 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 and Gemba.

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:

• Masters degree preferably in Chemistry or Biochemistry with 3 years of industry experience in a GMP / GxP or a comparable federally regulated environment of which 2 years are in a lead or supervisory role; OR
• Bachelors degree preferably in Chemistry or Biochemistry with 5 years industry experience in a GMP / GxP or a comparable federally regulated environment of which 2 years are in a lead or supervisory role.

Preferred Qualifications:

• Analytical laboratory experience in a GLP/GMP regulated environment is preferred.
• Experience in Trackwise Deviation Management software.
• Experience in Empower 3 software.

To all agencies: Please no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email the internet or in any form and/or method will be deemed the sole property of FUJIFILM unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired no fee or payment of any kind will be paid.

EEO Information

Fujifilm is committedto 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 ( or ).

Required Experience:

Manager