QA Specialist, GMP Learning and Development

Fujifilm
 Newbury Park, CA

Overview

Join FUJIFILM Diosynth Biotechnologies in our new facility location - Thousand Oaks, California! The QA Specialist, GMP Learning and Development will report directly to the Director, Quality Systems and Compliance at the FUJIFILM Diosynth Biotechnologies California (FDBC) location. The job holder will be responsible for developing and updating documents to support programs and system requirements. They will assist with curriculum development, as well as design and delivery of GMP and onboarding training for GMP staff.

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 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 Director Quality Systems and Compliance

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:

  • Bachelor’s degree preferred in a technical discipline.
  • 5+ years of relevant experience with Training/Learning and Development.
  • 3+ years of experience working within a GxP regulated environment.
  • 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 and the ability to communicate effectively with people in diverse and different settings.
  • Customer service skills.
  • Possesses sense of urgency; identifies challenges and problems and takes the initiative to identify solutions.
  • 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.

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