Document Control Supervisor

FUJIFILM Diosynth Biotechnologies • Santa Ana, CA

43d • $82,353 - $107,363 • Onsite

About The Position

We are hiring a Document Control Supervisor. The Document Control Supervisor will process and monitor controlled document activities through Document Control systems. They will also assign work and monitor performance of the Document Control and Labeling personnel. 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."

Requirements

• Bachelor's Degree
• At least 4 (four) years' relevant experience in a quality function within medical device or regulated industry. Preferably document control.
• Excellent Computer skills, specifically MS Word, Excel, Outlook,
• Experience working with eQMS, preferably MasterControl -managing, entering, report writing
• Current industry regulations, e.g. cGMP, ISO 13485, 21CFR820, MDD 93/42/EEC, IVDD 98/79/EC
• Ability to speak, write and read English.
• Good oral and written communication skills.

Nice To Haves

• Graphic design knowledge a plus.

Responsibilities

• Supervise Document Control Staff, providing work direction and feedback on performance.
• Provide department metrics reporting and performance against Key Performance Indicators KPIs
• Manage and help to maintain and process Document Change Requests (DCRs) for all controlled documents.
• Provide MasterControl Admin Support and Training support to all company personnel as needed.
• Manage and maintain Inventory of controlled records and coordinate shipment to off-site storage location.
• Support Quality Department during routine internal/external audits.
• Manage and support team with the creation/revision/printing/obsoletion of Label Masters, product inserts (IFU's) and other controlled documents
• Manage and support team with employee training records within EDMS and paper copies.
• Other duties as assigned

Benefits

• Medical, Dental, Vision
• Life Insurance
• 401k
• Paid Time Off

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Merchant Wholesalers, Durable Goods