FUJIFILM

  • Quality Control Manager - Microbiology

    Job Locations US-NC-Durham
    Posted Date 7 months ago(7 months ago)
    Requisition ID
    2018-2265
    Category
    Quality Control
    Company (Portal Searching)
    FUJIFILM Diosynth Biotechnologies U.S.A., Inc.
  • Overview

    It's an exciting time to be joining FUJIFILM.....

     

    We are currently hiring for a Quality Control Manager  - Microbiology for our beautiful, state of the art Durham location.  

    External US

    As the Quality Control Manager - Microbiology under limited direction, you will be required to plan, organize, direct and evaluate the routine activities of the Quality Control staff and laboratory functions to ensure the safety and reliability of products produced in compliance with company quality procedures and policies, as well as, various regulatory requirements.  Candidates for this position must have experience in Microbiology and Environmental Monitoring (EM) in a regulated pharmaceutical setting.  It is preferred to have experience supporting a manufacturing operation.  Strong candidates will have a working knowledge of additional QC functions in a regulated pharmaceutical setting.

     

    The manager may have supervisors, individual contributors, and hourly support staff reporting to them. Other responsibilities may include but are not limited to staff hiring, supervision, coaching, discipline and performing annual reviews. Duties include reviewing data and problem solving in support of microbiological analysis.  Additional responsibilities may include supervision of specified chemical or biological testing.

     

    The Quality Control Manager (Microbiology) candidate will also be involved in method development, method validation, method transfer and routine testing for incoming, in-process, release and stability testing on finished product, critical reagents and raw materials, as needed. 

     

    Required Skills & Abilities:

    • Demonstrated leadership, technical aptitude, and problem solving skills Must have excellent organizational, written communications and oral communication skills.
    • Must be flexible and able to manage and prioritize multiple tasks and assignments.
    • Must be able to effectively communicate technical information to a broad audience of varying technical knowledge
    • Must be goal-oriented and able to manage risks 
    • Develop staff to maximize contributions to team and company.
    • Detail oriented and accurate.
    • Ability to multi-task and prioritize work assignments with little supervision.
    • Computer proficiency required.
    • Knowledge of MS Office (Word, Excel, Outlook, PowerPoint).
    • Experience with TrackWise and LabWare LIMS, is desired.

    Qualifications:

    • Undergraduate degree in Microbiology, Biochemistry, Biotechnology, Biological, Chemistry or similar education/experience.
    • At least 8 years of microbiology laboratory experience in a pharmaceutical, biotechnology or other GMP regulated environment.
    • Previous supervising experience or demonstrated skills to lead and mentor a group cohesively, effectively and with compliance.

    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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