Specialist Quality Control - QC Instrumentation at FUJIFILM Holdings America Corporation

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.  The QC Instrumentation Specialist will author, review, approve laboratory procedures, instrument validation, CAPAs, deviations and change control assessments as they pertain to lab instrumentation.

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Specialist Quality Control – QC Instrumentation

QC Instrumentation Specialist, Quality Control is an individual contributor supporting the quality control analytical, microbiology and operations teams. The candidate must have advanced knowledge of instrument lifecycle from procurement through validation for both direct and indirect GMP impact systems. The candidate must have strong GMP experience with an emphasis on instrumentation as it pertains to QC laboratories. Experienced with a wide variety of instrumentation and their distinct maintenance and qualification needs. Must be able to quickly adapt and learn new instrumentation and processes. The position requires strong technical expertise, leadership, and project management skills. 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 participate in laboratory investigations, CAPAs, deviations, and change controls supporting instrumentation. The candidate must possess knowledge instrument IQ/OQ/PQ and 21CFR Part 11, CSV validation and be current with data integrity regulations as well as possess working knowledge of QMS systems and root cause analysis.

Reports to: Associate Director, Quality Control

Location: Thousand Oaks, CA

Travel: Up to 10%

Primary Responsibilities:

• Author, review, approve laboratory procedures, instrument validation, CAPAs, deviations and change control assessments as they pertain to lab instrumentation.
• Track and participate in the process lifecycle for new equipment acquisitions, transfers, and decommissions.
• Oversee internal laboratory instrumentation platform (s), including periodic review of performance and repair assessments.
• Serve as point of contact for instrument activities and proactively communicate work orders, projects, tasks, while seeking necessary approvals before initiation.
• Establish rapport with laboratory personnel as well as facilities team and respond promptly to equipment repair requests with prioritized follow-through on necessary work orders and vendor visit for repair.
• Work with laboratory personnel to troubleshoot potential instrumentation issues and be ready to open corrective maintenance work orders when applicable.
• Participate in laboratory investigations involving instrumentation including Unexpected Results (UR)/Out of Specification (OOS), root cause analysis.
• Reviews, assess and or owns changes to QC equipment via CAPA, Change Control and Work Orders to identify requirements necessary to maintain validated status.
• 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, Validation, Regulatory Affairs, MSAT, Process Development, Analytical Development and Quality Assurance) to ensure achievement of FDBCs objectives relating to QC instrumentation.

Qualifications:

• 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.
• Degree in Biochemistry, Molecular and Cellular Biology, Immunology, Biology or mechanical engineering preferred.
• GMP laboratory experience in a wide variety of techniques representing a variety of instrumentation.
• Advanced knowledge in analytical or microbiological methods and respective instrumentation.
• Prior experience and comfortable working with radioactive isotopes or radiation labs.
• Advanced knowledge of computer systems (e.g., Word, Excel, LIMS).
• Working knowledge of regulations and inspection/audit readiness.
• Advanced knowledge of QMS (CAPA deviation change control)
• Advanced knowledge of instrument IQ/OQ/PQ.
• Must possess demonstrated organizational skills that have proven results and the ability to be self-directed while managing multiple projects.
• Independent decision-making capability and ability to think conceptually and understand impact of critical decisions.
• Must possess excellent communication and technical writing skills.
• Team player,good interpersonal skills and a strong service-oriented mindset.
• Flexibility to travel as required to accommodate the business needs.
• Role model for FDBC values (Trust, Delighting our Customers, Gemba, Ghenki).

Salary and Benefits:

• $104,000 to $130,000, depending on experience
• Medical, Dental and Vision
• Life Insurance
• 401k
• Paid Time Off

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.