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QC Manager, Microbiology

Company: FUJIFILM Holdings America Corporation
Location: Durham
Posted on: November 26, 2022

Job Description:


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 FDBU, you determine what's possible.

As we grow our community, our capacity, and capabilities, we're looking for passionate people to join our team. Our North Carolina site sits in the renowned Research Triangle Park, the United States' largest hub of research and innovation. In such a dynamic location adjacent to many of the country's best places to live, it's no surprise that our passion is meteoric.

External US

QC Microbiology Manager is responsible for organizing and managing the Quality Control Microbiology Department and assuring that Microbiology Lab operations and testing are performed in compliance with applicable regulations, company specifications, procedures, and policies and current industry practices. The QC Microbiologist Manager is also responsible for leadership in all microbiological aspects relevant to manufacturing of product at Fijifilms Diosynth Biotechnologies , alongside training and qualification of all QC Microbiologist personnel.

The individual is recognized as a subject matter expert with regard to QC Microbiology laboratory practices and procedures and serves as the point-of-contact for activities related to laboratory support services, such as testing, enviroemntal monitoring and technbical support.

The QC Microbiology Manager contributes to proper control of all aspects of the Fujifilm Diosynth Biotechnologies manufacturing facility that may impact microbiological quality including manufacturing processes and equipment, materials utilized, physical facilities, environmental conditions, specifications, cleaning and sanitization, sampling and testing, employees, personnel practices and procedures, etc.

Other responsibilities include, but are not limited to:

  • Must maintain proficiency in all Microbiology laboratory methods, processes, and procedures.
  • Understands and complies with SOPs, Environmental, Health, Safety, and Quality requirements and applicable regulations. Maintains awareness of industry best practices.
  • Monitor sampling and testing as required for environmental and personnel monitoring, samples of, in-process product, and finished product.
  • Monitor sampling and testing as required for monitoring of critical systems, Water for Injection, Purified Water, Clean Steam, Clean Compressed Air, etc.
  • Monitor testing apparatus, solutions, media, cultures, and reagents as required.
  • Monitor quantitative and qualitative microbiological tests such as for media controls, enumeration, classification and speciation, antimicrobial effectiveness, etc. performed by all QC Microbiology personnel.
  • Trains and qualifies personnel for Aseptic Operations, Microbiological Sampling and Testing, and associated documentation. Trains Microbiologists, assigns tasks, monitors their performance, and reviews their testing and documentation.
  • Reviews Laboratory logbooks and Logs as detailed in applicable procedures. Produces periodic reports for tracking, evaluation of trends, associated metrics, etc.
  • Monitor calibration checks and performance checks of instrumentation and devices such as SAS, Metones, pH meters, and refrigerators.
  • Provides support of product development projects, investigations, monitoring of utilities systems, and the stability program.
  • Reports out of specification results to the Quality Control Director as required under established procedures.
  • Provides support for all testing, tasks, and documentation in support of Validation Studies including Process Validation, Media Fills, Method Validation, and development of analytical methods.
  • Writes and proposes revisions to Standard Operating Procedures, Analytical Methods, Lab Reports, and related Forms.
  • Performs reviews in support of Validation, Document Control and Change Control systems.
  • Responsible for co-coordinating and maintaining the stability program supporting new product development and existing products.
  • Tracks and reports Quality System Metrics relevant to testing, OOS Investigations, and training in support of Quality Systems Reporting to management.
  • Provides QA Support for Audits and Inspections. MAJOR ACTIVITIES AND RESPONSIBILITIES:

    In addition to performance of the essential functions, this position may be required to perform a combination of the following supportive functions, with the percentage of time performing each function to be solely determined by the manager based upon the particular requirements of the plant:
    • Responsible for participation in internal plant audits.
    • Functions as a technical advisor and problem solver for Microbiology related issues.
    • Participates in cross-training in QA and QC areas of responsibility.
    • Participates in the Safety Program to evaluate microbiological aspects of safety.
    • Promotes safe operating and working procedures. Counsels and trains QC Microbiology employees in safety awareness, ensuring that safety devices, equipment and personal protective equipment are used as required.
    • Provides support for process improvement teams and capital projects.
    • Must be able to effectively communicate with large groups and work collaboratively.
    • Excellent oral and written communication
    • Performs laboratory investigations for out of specification (OOS) microbiological testing results, and other microbiological laboratory non-conformances using established procedures.
    • Responsible for the trending of microbiological data and for communicating tredning findings to mfg, QA, etc. BACKGROUND REQUIREMENTS:

      Minimum Education Requirements

      BS degree in Microbiology, Biology, or related Science is required. Master's degree in Microbiology, Biology, or related science or an equivalent level of education, training, and experience is preferred.

      Desired Experience

      A minimum of 6-10 years of experience performing testing in a Quality Control Laboratory supporting FDA regulated manufacturing operations or equivalent level of experience. Excellent knowledge of FDA, USP, and cGMP requirements in a pharmaceutical quality control laboratory preferred.

      Specific Skills and Competencies
      • Demonstrated leadership, technical aptitude, and problem-solving skills
      • Must be flexible and able to manage and prioritize multiple tasks and
      • The individual must have excellent verbal and written communication skills and comfortably and clearly articulate issues with peers and colleagues at all levels in the organization.
      • Demonstrated capability in a cross-functional team environment, working cooperatively with others in effective ways that attain goals while encouraging teamwork and synergies throughout the organization
      • Capable of high through-put and high quality, right the first time work
      • Demonstrated subject matter expert in several relevant analytical disciplines such as Microbiologytesting and enviroenmental monitoring.
      • Proficient technical writing skills
      • Able to make informed and timely decisions independently
      • Capable of recognizing process gaps and implementing improvements
      • Demonstrated leadership traits that build and foster trust, respect, cooperation, and collaboration across the organization
      • Strong team skills, including the ability to coach/develop work teams, provide training, motivate/empower others, and resolve
      • Must be goal-oriented and able to manage risks
      • Must be proficient in analytical techniques and methodologies including membrane filtration methods, pour plate methods, gram stains, colony counting, and aseptic techniques.
      • Experience in antimicrobial effectiveness testing, sterility testing, method validation, cleanroom practices, and equipment qualification preferred. 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..... click apply for full job details

Keywords: FUJIFILM Holdings America Corporation, Durham , QC Manager, Microbiology, Executive , Durham, North Carolina

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