QC Sample Management Supervisor

The Sample Management Supervisor , under general direction, will be responsible for performing routine and non-routine support of samples submitted to the Quality Control (QC) Laboratory. This position works as part of the Sample Management team to manage the receipt, organization, and inventory of samples from manufacturing, clients, other Fujifilm facilities, and third parties . The Sample Management Supervisor arrange sample shipments for outsource testing and shipments to clients or other facilities and controls dispensing of samples for testing.

Company Overview

The work we do at FUJIFILM Diosynth Biotechnologies has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy, and drive - what FUJIFILM Diosynth Biotechnologies call Genki.

College Station, Texas may be a small, university town, but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of small-town life and the convenience of living close to the vibrant pulse of big cities. Eighty-seven percent of Texas' population lives within a 180-mile radius, so we are in the center of it all in Texas. And our site is nestled in the hub of innovation, representing a source of pride for the area.

Job Description

Essential Functions:

• Follow Standard Operating Procedures (SOP’s ), other related Good Laboratory Practices (GLP)/Good Manufacturing Practices (GMP) , and other site procedure documents (such as Chemical Hygiene Plan, SDS sheets) .
• Performs a variety of inventory tracking procedures (receipt, check-in, labeling inventory, transport, check-out, aliquot creation, etc.) for samples, critical reagents, reference materials, and other submissions to team.
• Perform shipments to external testing facilities, other Fujifilm sites, and clients .
• Responsible ensuring completion of cleaning Sample Management laboratories and stocking with necessary supplies .
• Stability coordination in assisting with pulls and/or aliquoting .
• Prepare sample management metrics .
• Oversee implementation and progress of objectives created by senior/upper management .
• Lead implementation and track progress of group projects .
• Performs deviation management for sample management group, including identifying preventative and corrective actions .
• Identify process improvements and assist in implementation of improvements .
• Establish, review, and update GMP documentation as needed .
• Ensuring all needed samples are entered in to site LIMS (ex. SmartQC )
• Organizes schedules and supervises resources for the team to support site operations .
• Lead team and department meetings .
• Interface with current and potential clients as well as interfaces with investigators during internal and external inspections/audits .
• Open and track necessary change controls .
• Discuss inventory requests with Project Managers, Stability Coordinators, and QC Project Coordinators
• Supervise and lead QC Sample Management staff, including hiring, firing, coaching, mentoring, and performance management functions.
• Ability to work cross functionally with other Quality Control groups, Quality Assurance, Manufacturing, and Project management to meet project and program timelines .
• Perform other duties as assigned .
  
  

Required Skills & Abilities:

• Leadership skills: Proven ability to motivate, inspire, and guide a team towards achieving goals.
• Compliance with policies: Understanding and adherence of company policies and procedures.
• Employee development: Experience in coaching, mentoring, and training team members to enhance their performance.
• Performance Management: Proven ability to set cleat expectations, monitor progress, and provide constructive feedback.
• Problem-solving skills: Capacity to analyze issues, identify solutions, and make informed decisions under pressure.
• Ability to provide and receive constructive feedback.
• Delegation skills: Ability to effectively assign tasks and responsibilities to team members based on their strengths.
• Ability to maintain detailed tracking and documentation clearly and accurately according to SOP’s.
• Communication Skills: Excellent verbal and written communication to effectively convey information and expectations to team members.
• Team Management Experience: Demonstrated experience managing and overseeing the performance of a team.
• Industry Knowledge: Thorough understanding of the industry practices and relevant regulations.
• Ability to evolve and adapt to new technologies to include electronic planning tools and laboratory information management systems (LIMS) .
• On-site attendance .
  
  

Working Conditions & Physical Requirements: The physical demands described here are representative of those that mus t 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, photocopies, telephone, calculator, and other office equipment as required .
• Ability to sit for long periods to work on a computer.
• Lift up to 15 lbs regularly and up to 30 lbs on occasion
• 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, gloves, specialized clothing including laboratory scrubs (pants and shirt) and appropriate shoes required in most areas associated with this position
• Hand dexterity to operate pipettes for performing aliquot procedures.
  
  

Preferred Q u a li f i c a t io n s:

• High School Diploma or GED, AND at least seven (7) years of relevant GMP Experience OR;
• Associate’s degree preferably in Biochemistry, Chemistry, Biology or related field AND at least Five ( 4 ) years of relevant GMP Experience and four (4) years of supervisory experience.
• Bachelor’s degree preferably in Biochemistry, Chemistry, Biology or related field AND at least three ( 2 ) years of relevant GMP Experience and two (2) years of supervisory experience.
• Master’s degree preferably in Biochemistry, Chemistry, Biology or related field AND at least two (2) years of supervisory 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.

EEO Information

Fujifilm is committed to 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 (FDBTHR@fujifilm.com or (979) 431-3500).