Senior Quality Control Specialist, LIMS

Overview

Join FUJIFILM Diosynth Biotechnologies in our new facility location - Thousand Oaks, California!  The Sr. 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 Sr. 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.

External US

Position Summary:

The Sr. 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 Sr. 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 (northwest Los Angeles area)

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 or Engineering in Computer Science / programming and/or similar field 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 Sys