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QC Supervisor

Research Triangle Park, North Carolina

The work we do at FUJIFILM Diosynth Biotechnologies has never been more important—and we are looking for talented candidates to join us. We’re 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. Here, you’ll work alongside and learn from some of the most dedicated scientists, engineers, and manufacturers in the industry. We’re proud to cultivate a culture that will fuel your passion, energy, and drive—what FDB calls Genki. Join us and discover a community that thrives on diversity and never scares away from a complex challenge. At FDB, you determine what’s possible.

 

Other duties and responsibilities include, but are not limited to:

  • Provides day to day tactical and logistical support for achieving department objectives
  • Supervises, coordinates, and assures the testing, review and final release materials in support of batch release
  • Assists in the hiring process for department staffing
  • Communicates department and personnel expectations and initiates disciplinary action where warranted
  • Reviews and approves: data, procedures, and timing in support of batch release
  • Anticipates and proactively manages potential problems that affect supply, compliance, and profit plan
  • Anticipates and reacts to technical problems, coordinates investigations and develops appropriate solutions; assuring that timelines and milestones are met
  • Evaluates and approves deviations / investigation reports
  • Collects and evaluates data to ensure that KPl’s are managed to targets.
  • Facilitates or coordinates lab validation activities
  • Assures staff is fully trained and immediately corrects gaps or deficiencies
  • Assures department safety and housekeeping agendas are sustained
  • Assures overall laboratory is fit for purpose, compliant, and production ready
  • Capable of overseeing, coordinating and ensuring execution of activities and/or projects according to timelines
  • Identifies and implements processes for improving time / cost efficiency for allocation of resources
  • Conducts performance evaluations and provides constructive feedback to direct reports on an ongoing basis
  • Coordinates workflow by scheduling and assigning workloads
  • Facilitates development opportunities to direct staff

 

MAJOR ACTIVITIES AND RESPONSIBILITIES:

  1. Supervises day to day activities in the areas of responsibility- 70%
  2. Assures the lab maintains a state of compliance readiness- 10%
  3. Personnel management responsibilities- 10%
  4. Other related lab duties- 10%

 

This position will report to a manager or director position in the QC Department. It will have direct reports

 

SCOPE MEASURES:

The QC supervisor reports to a member of the QC management team. The individual may supervise 10 or more analytical staff. The individual may have departmental budget approval authority within the guidance of the company authorization matrix. They are responsible for making purchase decisions that are in alignment with the approved operating budget. The position contributes to the successful realization of the company and department goals regarding profit plan, revenue, and compliance.

 

BACKGROUND REQUIREMENTS:

Minimum Education Requirements

  • BS/BA in science, preferably in chemistry, biochemistry, pharmaceutical sciences, or related technical field

Desired Experience

  • 5+ years related laboratory experience (4 years required with relevant MS degree)

Specific Skills and Competencies

  • Capable of coordinating activities and tasks in a high through-put and high quality, RFT work environment
  • Certified or capable of timely certification for Yellow Belt
  • Demonstrated subject matter expert in several analytical disciplines
  • Proficient technical writing skills
  • Able to make informed and timely decisions independently
  • Can manage multiple assignments in timely and effective manner
  • Effective communication skills with colleagues both within and outside of the department
  • Capable of recognizing process gaps and implementing improvements
  • Leadership traits that build and foster trust, respect, cooperation, and collaboration across the organization
  • Effective listening and coaching skills
  • Communicate skills that effectively facilitate project or workflow efficiency and/or distribute information

 

FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 – 130 and Export Administration Regulations in 15 C.F.R. Part 730 – 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company’s ability to secure an export authorization. FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class.

 

FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class.

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