Position Description

We are hiring a Document Control Manager. The Document Control Manager will manage Document Control personnel and related systems.  They will provide guidance and supervision of Document Control functions, which include the creation, revision, approval, maintenance and issuing/printing of product labels, SOP’s, posters, forms and other controlled documents.  They will also manage training recording and comprehension verification and be in charge of the development, maintenance and implementation of electronic document management system improvements and revisions.

At FUJIFILM Irvine Scientific (dba FUJIFILM Biosciences), we turn curiosity into breakthroughs that advance the field of life sciences. By offering a comprehensive portfolio of products and services in cell culture media, discovery research reagents, recombinant growth factors and proteins, fine chemicals, and critical assay materials, we partner with the brightest minds in biotech and pharma to tackle the world’s biggest health challenges.

Imagine being part of a team that enables life-changing discoveries like new vaccines, therapies, and advancements in regenerative medicine. Our culture fosters curiosity, collaboration, and innovation, and we pride ourselves on delivering unparalleled quality and service to our partners. If you’re ready to make an impact, your future belongs with us at FUJIFILM Irvine Scientific (dba FUJIFILM Biosciences).

Our headquarters in Santa Ana, California, is surrounded by world-class schools, lush parks, and scenic beaches like Laguna and Huntington, making it an ideal place to live, work, and explore. With additional campuses across the US, Europe, China, and Japan, we offer opportunities to make a difference worldwide.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers

Responsibilities:

• Manage System for controlled documents, training and label control.
• Develop, execute and report on assigned Document Control objectives.
• Provide work direction, measurements of results to assigned personnel:
  • Production of labels for manufacturing, including assuring that label masters are revised and approved, that label inventory is accurate and monitored
  • Coordination of product inserts creation, translations, issuance, printing and inventory maintenance of the most current revisions.
  • Identification, qualification and coordination of new label or printing suppliers (as per as needed basis).
• Assist with creation and revisions of Raw Material Specifications and Inspection Reports.
• Make recommendations for the improvement of internal procedures regarding efficiency, cost reduction and improved Document Control programs.
• Assist and support Regulatory Affairs department during the submission of regulatory files with by providing related technical documents.
• Assist and support the QA Auditing department during audits, by providing technical documents and support needed.
• Manage Electronic QMS software (MasterControl)

Required Skills/Education:

• Bachelor’s degree required
• A minimum of five (5) years of Quality Assurance and or Document Control in a medical device manufacturer or equivalent.
• A minimum of four (4) years of supervisory or management experience preferred.
• Experience with MS Office applications/software
• Overall knowledge of Adobe InDesign, Photoshop, and Illustrator software preferred
• Experience implementing, maintaining, updating, improving eQMS software – MasterControl preferred
• Ensure that requirements are met in all regulatory, compliance and registration functions as prescribed by the FDA’s GMPs (QSR), ISO 13485, MDD 93/42, MDR 2017/745, IVDD 98/79/EC, IVDR 2017/746, ISO 14971, Brazilian GMPs, Health Canada MDR, Australian Medical Device regulations and regulatory requirements for product registrations where products are distributed worldwide.
• Current industry FDA regulations, i.e. cGMP, 21 CFR 820, ISO 13485, Canadian Medical Device Regulations, Code of Federal Regulations, Excel, Novell, Windows 2000 or similar.
• Knowledge of Quality Assurance Document Control Systems.
• Ability to speak, write and read English fluently
• Good oral and written communication skills. 

Salary and Benefits:

• For California, the base salary range for this position is $103,093 - $134,204 annually. Compensation for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience, location, etc.).
• Medical, Dental, Vision
• Life Insurance
• 401k
• Paid Time Off

*#LI-onsite       

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.

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 (fisihr@fujifilm.com).