FUJIFILM Irvine Scientific, Inc. (FISI) is a worldwide leader in the innovation and manufacture of cell culture media, reagents, and medical devices for researchers and clinicians. The company provides unrivaled service and quality to scientists working in biopharmaceuticals, cell therapy, regenerative medicine, assisted reproductive technology and cytogenetics, and industrial cell culture for the large-scale production of biotherapeutics and vaccines. FISI adheres to ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. The company’s consultative philosophy and expertise in cell culture and compliance provide customers with unique capabilities and support. For over 50 years, FISI has remained uniquely flexible and focused on media while becoming a strategic global leader in media products and services.  FUJIFILM Irvine Scientific, Inc. is a subsidiary of FUJIFILM Holdings America Corporation, reporting to FUJIFILM Holdings Corporation.

We are hiring a Master Data Analyst I. The Master Data Analyst I will ensure that recipes, processes, and procedures are entered, reviewed, and processed assuring quality of products and compliance in accordance with GMP and ISO13485. They will monitor and edit technical elements of manufacturing documents for accuracy and completeness.

Responsibilities

• Accurately enter data for setting up router, master recipe, material master, and inspection plan documents.
• Ensure requirements for MSS and GMP Manufacturing are completed and facilitate task movement by collaborating with other departments based on procedures, such as EHS assessment and approval prior to creation of any new chemical raw materials.
• Coordinate system inputs for processing routers and formulations. Assign part numbers for raw materials and finished goods.
• Augment existing master data records through effective master data stewardship and compliance with good documentation practices.
• Maintain team-shared log sheet with part number assignments for both raw materials and finished goods.
• Contribute to meetings and provide data driven input to process improvement ideas and work status updates for relevant work or projects.
• Serve as a cross-functional liaison between various departments and carry out necessary action(s) involved in ERP/SAP.
• Act as the primary contact for Commercial Team on new custom formulations.
• Support new product development and technology transfer between R&D and manufacturing.
• Maintain and revise department SOPs and DTIs where applicable.
• Participate in process improvement and system projects based on Operations Department priorities.
• Ensures that operational support needs and downstream implications are addressed when developing solutions.
• Assisting in data migration activities for importing legacy data from Jeeves ERP system to SAP based on Commercial needs.
• Any other tasks as assigned by the line manager. 

Required Skills/Education 

• B.S. or B.A. in areas of Science, Business, Engineering, or equivalent experience.
• 2-3 years of data entry experience or equivalent.
• Ensure attention to detail is consistent for master data tasks.
• Ensure on-time delivery of master data requests.
• Ability to adapt to work independently and within a team effectively.
• Excellent command in use of computer and technology.
• Serve as a cross-functional liaison between various departments and carry out necessary action(s) involved in ERP/SAP.
• Demonstrate capabilities to maintain and adapt to Master Data processes across multiple locations and business units.
• Excellent Excel and Power Point software skills.
• Conversion between Units of Measure
• Experience from master data maintenance in an ERP system. SAP experience is a plus.
• Preferred knowledge of GMPs, USP, and ISO 9001/EN13485.
• Experience in writing/revising Standard Operating Procedures is a plus.

For California, the base salary range for this position is $51,175 to $81,650 annually. Compensation for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience, location, etc.).

Fujifilm 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, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (includes pregnancy, childbirth, breastfeeding and related medical conditions), and sexual orientation, and any other status protected by federal, state, or local 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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