Quality Control - Supervisor, Raw Materials

The Quality Control Raw Material Supervisor, will be responsible for planning, organizing, and directing raw materials received, tested, and released by Quality Control for GMP Manufacturing. The raw material supervisor must have a sound understanding of USP and EP compendial monographs. The supervisor will work with Materials Management to ensure incoming raw materials are sampled and tested in a timely manner in order to meet deadlines and stay on schedule. The supervisor will attend planning meetings as needed to prioritize material release supporting multiple projects across three manufacturing sites.

Essential Functions

· Supervise the QC Raw Material group, to include scheduling staff, prioritizing raw material release, review and approved sampling and testing records.

· Coordinate and oversee Raw Material testing and release in SAP.

· Coordinate and manage external testing labs to include shipping samples, tracking progress, and managing timelines. Obtain quotes and process PR's. Review and approve testing results.

· Write, revise, and review Standard Operating Procedures (SOPs) and other Good Manufacturing Practices (GMP) documentation as needed.

· Review and approve new and revised item specifications.

· 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 the audit team during internal and external inspections / audits.

· Follow all established laboratory, regulatory, safety, and environmental procedures.

· Lead and contribute to OOS investigations, develop and implement CAPAs contributing to process improvements.

· Perform other duties as assigned.

 

Required Skills & Abilities

· 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.

 

Minimum Qualifications

· 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 OR

· Master's Degree preferred in Chemistry, Biochemistry, or an applicable scientific discipline with at least three (3) years' industry experience in a GMP / GxP or a comparable federally regulated environment.

· Previous supervising experience or demonstrated skills to lead and mentor a group cohesively, effectively, and in a compliant manner.

 

 

Preferred Qualifications

· 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.

 

Salary Starting salary will be commensurate with education and experience.

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 place. 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.