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Quality Assurance - Risk Assessment Manager

Company: FDBT - FUJIFILM Diosynth
Location: College Station
Posted on: May 28, 2023

Job Description:


Follow Your Genki to FUJIFILM Diosynth Biotechnologies (FDB) -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 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 FDB call Genki.Summary: - The Quality Assurance (QA) Risk Management Manager position will be responsible for providing leadership to the Texas site in ICH Q9 principles of Risk Management. - Ability to facilitate risk assessments, train future facilitators, provide oversight and tracking of remediation actions, and communicate to leadership on the status.

External US

Essential Functions:

  • Risk Management Delivery
  • Support to the organization in leading the Risk Management process
  • Lead/facilitate Risk Management sessions
  • Document and manage all Risk Assessments for the site
  • Develop and issue weekly and monthly metric reporting
  • Align Risk Management tools, ranking and filtering
  • Manage Action item/Remediation activities
  • New Business Growth
  • Support client due diligence and Quality audits as well as regulatory inspections.
  • Work with Quality management to implement and grow phase-appropriate quality systems that will enable cGMP manufacturing of pre-clinical to commercial products.
  • Compliance
  • Ensure self, and team, have no overdue training, or site actions. Support other QA teams and other functions in completion of site actions.
  • Provide cGMP assistance to other functions such as Manufacturing, Facilities and QC.
  • Promptly notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
  • All other duties as assigned.Required Skills & Abilities:
    • Excellent written and oral communication skills.
    • Excellent organizational, analytical, data review and report writing skills.
    • Ability to set personal performance goals and provide input to departmental objectives.
    • Ability to multitask and easily prioritize work.
    • Ability to work independently with little supervision.
    • Proficient in Microsoft Excel, Word and PowerPoint.
    • All candidates must have a working knowledge of cGMP regulations for the production of drug, biologics or vaccine products.
    • Understanding of biologic product life cycle as ICH Q8, Q9, and Q10
    • Experienced in FMEA, Fault Tree Analysis, Ishikawa Cause & EffectWorking Conditions & Physical Requirements:The physical demands described here are representative of those that must 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.
      • Ability to sit for long periods to work on a computer.
      • Potential for exposure to chemicals, gases, fumes, odors, dusts, and other hazardous materials.
      • Ability to wear personal protective equipment including but not limited to safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt), cleanroom (ISO 8 to ISO 5) gowning material and appropriate shoes required in most areas associated with this position.
      • Lifting up to 25 pounds on occasion.
      • Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
      • Must be willing to work flexible hours.
      • Ability to work weekends and off-shift hours, as needed to support manufacturing activities.
      • Must be willing to travel occasionally, as needed.
      • Attendance is mandatory.Qualifications:
        • Bachelor's degree in a science-related field and 10 years' relevant experience
        • Associates degree with 12 years' of related experience
        • 6 years cGMP experience
        • At least 4 year's management or supervisory experiencePreferred Qualifications:
          • Degree in Biology, Chemistry or EngineeringWe are an equal opportunity and affirmative action employer. - All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law. -If an accommodation to the application process is needed, please e-mail or call 979-431-3528.#LI-SB2

Keywords: FDBT - FUJIFILM Diosynth, College Station , Quality Assurance - Risk Assessment Manager, Executive , College Station, Texas

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