Quality Assurance, GMP Learning & Development

Overview

Join FUJIFILM Diosynth Biotechnologies in our new facility location - Thousand Oaks, California! The QA Specialist, GMP Learning and Development will report to the QA Senior Manager, GMP Learning and Development at the FUJIFILM Diosynth Biotechnologies California (FDBC) location. The job holder will be responsible for the support of the GMP Learning and Development program.  The QA Specialist, GMP Learning and Development will help assist in the GMP Training program for the site using the company’s Learning Management System (ComplianceWire).  The Specialist will also assist in the management of GMP related documents using Document Management System (Veeva). Responsible to have intermediate knowledge of FDA regulations concerning Good Manufacturing Practices (GMP) to ensure compliance to quality standards for documentation, training, and records management.

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QA Specialist, GMP Learning and Development

Join FUJIFILM Diosynth Biotechnologies in our new facility location - Thousand Oaks, California! The QA Specialist, GMP Learning and Development will report to the QA Senior Manager, GMP Learning and Development at the FUJIFILM Diosynth Biotechnologies California (FDBC) location. The job holder will be responsible for the support of the GMP Learning and Development program.

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 QA Specialist, GMP Learning and Development will help assist in the GMP Training program for the site using the company’s Learning Management System (ComplianceWire).  The Specialist will also assist in the management of GMP related documents using Document Management System (Veeva). Responsible to have intermediate knowledge of FDA regulations concerning Good Manufacturing Practices (GMP) to ensure compliance to quality standards for documentation, training, and records management.

Responsible to create training curriculum and assist in the delivery of effective training to adult learners, multi-task across multiple functional areas, and can be flexible to meet the demands of a multi-product clinical phase cellular therapy company that is transitioning toward commercial phase.

 

Reports to            QA Senior Manager, GMP Learning and Development

Work Location      Thousand Oaks, CA 

Travel                   Not required

 

Primary Responsibilities:

• Assist with the design and delivery of GMP and onboarding training for GMP staff
• Assist with curriculum development and maintenance for GMP staff
• Assist with internal audits and inspections
• Assist with ongoing continuous improvement of LMS (ComplianceWire)
• Develop and update documents to support of program and system requirements
• Prepare oral and written communications to management with clarity and accuracy
• Assist in the support of Document Management Team using Veeva Vault
• Stays current with applicable regulations including federal, state, local and company-specific practices.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Investigate and support training related quality events, such as deviations, CAPAs and change controls

 

Qualifications:

• Master of Science (M.Sc.) with 2+ years of applicable industry experience; or
• Bachelor of Science (B.Sc.) with 4+ years of applicable industry experience; or
• Associate Degree with 6+ years of applicable industry experience; or
• High school diploma with 9+ of applicable industry experience
• Knowledge of FDA regulations concerning Good Manufacturing Practices (GMP).
• Experience administrating Veeva Vault and ComplianceWire or alternate Learning Mgt. System
• Working knowledge of Sharepoint desired
• Practical understanding of documents and records used within the Pharmaceutical industry
• Self-motivated, flexible & creative, able to prioritize, multi-task and work in a fast-paced & demanding environment.
• Awareness of and ability to learn emerging learning technologies (LMS technologies, Captivate, Articulate etc.).
• Preferred prior experience working within a LMS, ComplianceWire.

• • Strong verbal communication and technical writing skills.
  • Strong interpersonal skills a