- Manage the QC Raw Material group, including supervision, scheduling, discipline, and performing annual review assessments.
- Coordinate and oversee Raw Material testing and release across two GMP warehouses in SAP.
- Coordinate and manage external testing labs to include shipping samples, tracking progress, and managing timelines. Obtain quotes and process PR’s. Review testing results and COAs.
- Write, revise, and review Standard Operating Procedures (SOPs) and other Good Manufacturing Practices (GMP) documentation as needed.
- Review and approve new and revised material specifications.
- Work to expand FDBT raw material testing capabilities to include ID testing by FTIR / Raman spectroscopy, HPLC methodologies, and wet chemistry.
- Review and approve data / reports to release raw materials from a quarantine status.
- Ensures laboratory, sampling booth, and associated equipment are in compliance to established specifications and procedures.
- Reports excursions/out of specifications results and conducts investigations as needed.
- Assure the implementation of appropriate and timely corrective actions.
- Work closely with Program Managers, Materials Management and Manufacturing to improve the effectiveness and timeliness of Raw Material testing and release.
- Interface with investigators during internal and external inspections / audits.
- Follow all established laboratory, regulatory, safety, and environmental procedures.
- Identify deviations and report possible preventative and corrective actions using Trackwise.
- Perform other duties as assigned.
Required Skills & Abilities:
- Sound understanding of analytical instrumentation and methodologies. For example, chromatography and spectrophotometry, wet chemistry.
- Operate as a team leader, coordinate staff scheduling and training.
- Ability to follow safety procedures outlined in the Chemical Hygiene Plan.
- Utilize SDS sheets to properly assess chemical hazards, spill response procedures, and PPE requirements if indicated.
- 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.
- Bachelor’s degree preferred in Chemistry, Biochemistry, or an applicable scientific discipline with at least five (5) years’ industry experience in a GMP / GxP or a comparable federally regulated environment of which two (2) years are in a supervisory or managerial role.
- Analytical laboratory experience in a GLP/GMP regulated environment is preferred.
- Experience in Systems, Applications and Products (SAP) software.
- Experience in Trackwise Deviation Management software.
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 979-431-3528.