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Specialist/Sr. Specialist, Quality Control

Company: FUJIFILM Holdings America Corporation
Location: Thousand Oaks
Posted on: November 16, 2022

Job Description:

Overview









Join FUJIFILM Diosynth Biotechnologies in our new facility location - Thousand Oaks, California! The Specialist/Senior Specialist Quality Control will report directly to the Associate Director, Quality Control at the FUJIFILM Diosynth Biotechnologies California (FDBC) location. The job holder will be responsible for authoring, reviewing and approving laboratory procedures, analytical methods qualification/transfer and/or validation protocols and reports. They will lead implementation of new analytical methods at QC, including qualification, transfer and validation strategies for FDB's cell therapy product assays.













External US









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 our new FDB facility in Thousand Oaks, CA and help manufacture the next cell 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 Genki.Job Description:The Specialist/Senior Specialist, Quality Control is an individual contributor responsible for driving analytical method qualifications/transfers and validation at FDB's Quality Control Bioanalytical laboratories. Position requires strong technical expertise, leadership and project management skills. The candidate must have strong GMP laboratory, bioassay, cell biology or immunology experience. Position requires a self-motivated, detailed oriented, flexible and creative expert, able to prioritize, multi-task, and work in a fast-paced & demanding environment. The selected individual will actively participate on laboratory investigations, data and trend analysis, method qualification/transfers and validation activities and process improvement.Reports to: Associate Director, Quality ControlLocation: Thousand Oaks, CATravel: Up to 10%Primary Responsibilities:

  • Author, review and approve laboratory procedures, analytical method qualification/transfer and/or validation protocols and reports
  • Lead implementation of new analytical methods at QC, including qualification, transfer and validation strategies for FDB's cell therapy product assays
  • Ensures availability of materials and equipment required to implement analytical methods at QC
  • Train and execute analytical methods associated to method qualification, transfers and/or validations
  • Assess analytical method performance and investigate assay trends
  • Participate in laboratory investigations including Unexpected Results (UR)/Out of Specification (OOS), root cause analysis and implement solutions
  • Identifies and implements corrective/preventive actions (CAPA)
  • Reviews and assess proposed changes to assays and/or QC equipment via CAPA, Change Control and Work Orders to identify requirements necessary to maintain validated status
  • Analyze data and summarize data and results into reports
  • Support phase-appropriate QC capabilities, business processes, and procedures
  • Maintain current knowledge base of regulations and policies to ensure that the QC function remains in compliance with applicable company requirements and global regulations. Interface with other departments (e.g., Facilities, Information Technologies, Manufacturing, Regulatory Affairs, and Quality Assurance) to ensure achievement of FDB's objectives relating to QC analytical method readiness for new product introductions, including compliance with all applicable standards.Qualifications:
    • For Specialist Role:
      • Bachelor of Science (B.Sc.) with 5+ years of experience or an equivalent combination of education; or Master of Science (M.Sc.) with 3+ years of experience; or PhD in Science with 0-3 years of experience
      • For Senior Specialist Role:
        • Bachelor of Science (B.Sc.) with 7+ years of experience or an equivalent combination of education; or Master of Science (M.Sc.) with 5+ years of experience; or PhD in Science with 3+ years of experience
          • Excellent project management skills and proved experience leading projects with history of achieving results and outstanding outcomes
          • Experience in assay transfer and qualification/validation; T-cell related experience is preferred
          • Independent decision-making capability and ability to think conceptually and understand impact of decisions critical
          • Must possess demonstrated organizational skills that have proven results in the ability to be self-directed while managing multiple projects
          • Must possess excellent communication and technical writing skills
          • Team player and good interpersonal skills
          • Knowledge of relevant regulations and regulatory guidance
          • Quality Control and/or Analytical Development experience in the pharmaceutical industry supporting cGMP areas, including method transfers and assay qualification/validation is required
          • Experience in cGMP cell therapy manufacturing and/or testing facility, preferred
          • General laboratory investigation, OOS, and root cause experience is required.
          • Ability to work independently, able to take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance, as necessary.
          • Flexibility to travel as required to accommodate the business needs.
          • Role model for company core values of trust, delighting our customers, Gemba, and Genki.Join us! - FDB is advancing tomorrow's medicine, impassioning employees to chase the impossible and continually expand their potential. - We are a company of emboldened goal seekers - driven by an innate desire to better ourselves, our families, our workplace, our company, our community and the world at large. -FDBC is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, religious creed, sex (includes pregnancy, childbirth, breastfeeding, and related medical conditions), and sexual orientation and any other status protected by state or federal law. -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, Thousand Oaks , Specialist/Sr. Specialist, Quality Control, Other , Thousand Oaks, California

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