Senior Specialist, Quality Control - LIMS

Join FUJIFILM Diosynth Biotechnologies in our new facility location - Thousand Oaks, California! The Quality Control Senior Specialist will report directly to the Senior Manager, Quality Control at the FUJIFILM Diosynth Biotechnologies California (FDBC) location. The job holder will be responsible for planning and implementing the design, configuration and/or customization of LIMS according to business requirements . They will lead optimization of LIMS activities in collaboration with functional areas, which include defining LIMS workflows, maintain dynamic/static data in LIMS, perform and participate in GMP review, LIMS Access review and internal/external audits.

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.

The Senior Specialist, Quality Control supports Fujifilm Diosynth Biotechnologies California (FDBC) QC with the business analysis, design, development, implementation, validation, and support of existing and new Laboratory Information Management Systems (Labware LIMS) and other lab applications.  The Sr. Specialist, Quality Control is a customer facing role, working in close collaboration with Quality Control (QC), Quality Assurance, Manufacturing, and Information Technology (IT) teams.

The Senior Specialist will follow FDBC methodologies for systems and project governance, leverage tools & techniques to capture business and functional requirements and use approved corporate documentation templates and systems for software development lifecycle documentation.

Reports to:

Senior Manager, QC

Location:

Thousand Oaks, CA (hybrid)          

Travel:      

10%

Primary Responsibilities:

• Plan and implement the design, configuration and/or customization of LIMS according to business requirements. (i.e., Configure Analysis, Sample Plan and Product Specification, Electronic Lab Notebook (ELN) Templates, calculations etc. in Labware LIMS for New Products Introduction)
• Lead optimization of LIMS activities in collaboration with functional areas, which include defining LIMS workflows, maintain dynamic/static data in LIMS, perform and participate in GMP review, LIMS Access review and internal/external audits.
• Evaluate product enhancements and capabilities as required.
• Fully lead, manage, and own project implementations.
• Triage, delegate and manage the LIMS project deliverables and priorities with cross-functional leads.
• Work with subject matter experts (SMEs) to clarify and document user requirements. Create and maintain application procedures and system configuration documents. Author and review SOP's.
• Translate functional business requirements into technical requirements and specifications. Ensure project deliverables meet business requirements
• Own Quality Management System records (Deviations, CAPAs, Change Control's) to completion.
• Support creation, review and executing system validation documentation (IQ, OQ and PQ) and change control documentation.
• Serve as a point of contact for LIMS and provide support and training on LIMS to end users for any new enhancements or major changes implemented in LIMS.
• Responsible for management of equipment and supplies related to LIMS, which includes vendor coordination, setting up printers, ordering supplies for printers.

Qualifications:

• 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
• Advanced knowledge of LIMS software / configuration/ system usage, and/or laboratory experience.  Experience with Labware LIMS version 7.0 or greater software is a plus. Experience with Product lot management, Environmental Monitoring and Stability samples in LIMS is a plus.
• Working knowledge of document management and lifecycle
• Working knowledge of quality systems and their interconnections (e.g., LIMS and document revisions)
• Advanced knowledge of sampling plan lifecycle and inventory management
• Basic knowledge of product testing, data analysis, and reporting.
• Working knowledge of Validation Life Cycle and knowledge of GAMP, GDP's (GCP, GLP, and GMP), 21-CFR Part 11 regulation of Electronic Records, Electronic Signatures, and Audit Trails.
• Advanced knowledge of Quality Management System (CAPA, deviation, change control)
• Basic knowledge in Reporting software program is a plus (Power BI or Tableau or Crystal Reports).
• Basic knowledge of Lab-associated systems (Empower) and/or ERP Systems (SAP, Oracle)
• Role model for company core values of trust, delighting our customers, Gemba, and Genki.

Salary and Benefits

• $120k to $140k salary, depending on experience.
• Medical, Dental, 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.