QC Manager - Instrumentation

Company: FUJIFILM Holdings America Corporation
Location: Holly Springs
Posted on: March 17, 2023

Job Description:

Overview









The work we do at FDB 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 manufacture 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 we call GenkiWe are growing our locations and are investing more than $2 billion into establishing a new -large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America. The new site will offer end-to-end solutions -to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also -provide -automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States. -We are looking for a QC Manager- Instrumentation, who wants to participate in our journey to establish the largest end-to-end cell culture CDMO facility in North America. But more importantly, someone who wants to be a part of the largest growth journey that we in FUJIFILM have ever entered. -We offer the possibility of joining our dedicated team with a focus on ensuring QC instrumentation and equipment meet the needs of our new QC Laboratory to support the new cGMP manufacturing facility.As the QC Manager- Instrumentation, you will be assuring timely and high-quality equipment selection, installation, qualification, service contracts, vendor relations, software (including LIMS) and relevant SOPs to support cGMP operations. You will be reporting initially to the Head of Quality and will eventually report to the Head of QC. - You will join an organization focusing on growth, people, and a steep learning curve as well as a diverse workplace with people driven to make a difference.













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Job Responsibilities

• Lead the QC Laboratory equipment selection, software, and digital solutions -
• Ensure delivery and implementation of solutions which -fulfil -requirements and expectations---by the end users -
• Build and maintain awareness and knowledge of regulatory, legal, or quality requirements impacting the QC Laboratory instrumentation and software
• Author and implement project plans, validation plans, user requirements, and standard operating procedures
• Collaborate with our global partners to assure alignment within our Fujifilm network.
• Report on status and manage escalations
• Ensure systems remain in a validated state and manage their lifecycle from release to retirement
• Identify and capture new opportunities to improve or optimize QC Lab systems -
• Ensure optimal quality inspections (internal and external)Required SkillsWe are looking for a candidate with the following background and skill sets:
  • Master's or Bachelor's degree within IT, Physical, Chemical or Biological Science, Technical Engineering or equivalent - -
  • 8+---years---experience from similar role in large Pharma/ Biotech projects
  • Experience in QC Laboratory equipment selection, qualification, and managing service contracts
  • Lead implementation and operations of LIMS
  • Strong working knowledge of QC Laboratory equipment and software
  • Solid knowledge of Computer System Validation process
  • Must be a self-starter, be able to work with minimal supervision and effectively manage multiple projects
  • Collaborative positive attitude with the willingness to work with global peers toward company and department goals.
  • Well versed in cGMP/ICH/FDA/EU regulations and guidelines
  • Excellent oral and written communications skills in EnglishThe Company requires that the successful candidate hired for this position be fully vaccinated for COVID-19, absent being granted an accommodation due to medical, pregnancy, or sincerely held religious belief or other legally required exemption.FDBN 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.FDBN 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. If an accommodation to the application process is needed, please email lena.lee@fujifilm.com.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.
    
    
    
    

Keywords: FUJIFILM Holdings America Corporation, Cary , QC Manager - Instrumentation, Executive , Holly Springs, North Carolina