Position Overview

The Specialist, QA Documentation Managementwill support the site documentation management program.The role is responsible to have intermediate knowledge of regulations concerning Good Documentation Practices (GMP) to ensure compliance to quality standards for documentation, training, and records management. Responsible to support the documentation management curriculum structure and assist in the delivery of effective documentation practices to end users, 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.

Company Overview

Join us! FUJIFILM Diosynth Biotechnologies 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.

Job Description

Department: Quality Assurance

Location: Thousand Oaks, CA

Reports To: Senior Manager, Documentation Management

MAJOR ACTIVITIES AND RESPONSIBILITIES:

• Assist with the design of documentation management material using ACOVA principles and Agile concepts.

• Deliver GDP courses and guide the onboarding training for staff on proper GDP..

• Assist with curriculum development and maintenance for electronic Documentation Management System (eDMS).

• Assist with internal audits and inspections.

• Assist with ongoing continuous improvement of eDMS.

• Develop and update documents to support of the site documentation management program and system requirements.

• Prepare oral and written communications to management with clarity and accuracy.

• Assist in the support of Training 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 cGDP and all other relevant company training requirements.

• Investigate and support documentation management 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 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

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.

SALARY AND BENEFITS:

• $104,000-$130,000, depending on experience

• Medical, Dental and Vision

• Life Insurance

• 401k

• Paid Time Off

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.

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBCHR@fujifilm.com).

Job Locations US-CA-Thousand Oaks

Posted Date 6 days ago (3/13/2025 5:23 PM)

Requisition ID 2025-33657

Category Quality Assurance

Company (Portal Searching) FUJIFILM Diosynth Biotechnologies