Specialist GMP, Learning & Development

The Specialist, GMP Learning and Development will support the site training program. The role is responsible to have intermediate knowledge of regulations concerning Good Manufacturing Practices (GMP) to ensure compliance to quality standards for documentation, training, and records management. Responsible to support the training curriculum structure 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.

Department: Quality Assurance

Location: Thousand Oaks

Reports To: Senior Manager, GMP Training and Development

MAJOR ACTIVITIES AND RESPONSIBILITIES:

• Assist with the design of training material using ADDIE principles and Agile concepts.
• Deliver GMP courses and guide the onboarding training for GMP staff following adult learning principles.
• Assist with curriculum development and maintenance for GMP Learning Management System (LMS).
• Assist with internal audits and inspections.
• Assist with ongoing continuous improvement of LMS.
• Develop and update documents to support of the site Training program and system requirements.
• Prepare oral and written communications to management with clarity and accuracy.
• Assist in the support of Document Management Team using the current electronic Document Management System (eDMS).
• Stay current with applicable regulations including federal, state, local and company-specific practices .
• Ensure 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.
• Support Site wide projects using Project Management skills and tools.

BACKGROUND REQUIREMENTS (Education, Behavioral, Professional & Technical Capabilities Experience):

Education / Experience

• Master of Science (M.Sc.) with 3 years of Life Science Industry experience; or
• Bachelor of Science (B.Sc.) with 5 years of Life Science Industry experience; or
• Associate Degree with 7 years of Life Science Industry experience

Behavioral Competencies

• Communication (proficient skill)
• Self-starter (proficient skill)
• Problem solving (proficient skill)
• Critical / logical thinking / analysis (proficient skill)
• Risk management (proficient skill)
• Project management (proficient skill)
• Time management (proficient skill)
• Conflict Resolution (proficient skill)
• Teamwork and Collaboration (proficient skill)
• Negotiation skills (proficient skill)
• Innovative thinking (proficient skill)
• Decision making (proficient skill)
• People management/ development (basic skill)
• Strategic leadership (basic skill)
• Customer service-oriented (proficient skill)
• Goal/ results oriented (proficient skill)
• Detail oriented (proficient skill)

Technical Competencies

• cGMP (working knowledge)
• Aseptic techniques (advanced knowledge)
• Biopharmaceutical operations (working knowledge)
• Quality systems (advanced knowledge)
• Computer applications (working knowledge)
• GXP enterprise systems (advanced knowledge)
• Regulations and compliance (working knowledge)
• Creating and approving technical documentation (advanced knowledge)
• Process and method qualification (working knowledge)
• Managing process introduction tasks (working knowledge)

WORK ENVIRONMENT:

Work is generally performed in a manufacturing and office environment, with some laboratory and warehouse environment work. May need to lift less than 10 pounds weight from time to time.

PHYSICAL REQUIREMENTS:

Subject to extended periods of sitting and/or standing, vision to monitor and moderate noise levels.

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.