QC LabWare Admin - FISI - FUJIFILM Irvine Scientific

FUJIFILM Irvine Scientific, Inc. is a global leader in the innovation and manufacture of cell culture solutions for Life Science and Medical markets, providing products and services that assist customers in advancing healthcare initiatives. Working across discovery research, cell and gene therapy, reproductive medicine and cytogenetics, as well as the large-scale production of biotherapeutics and vaccines, the Company is trusted by researchers, manufacturers, and clinicians worldwide. For over 50 years, FUJIFILM Irvine Scientific’s Mission has been to empower all who bring medicines and treatments to life with unmatched quality and responsiveness in its products and custom solutions, providing customers with the vital resources needed to enrich human lives through innovative, accessible therapies. The Company’s facilities adhere to both ISO and FDA regulations, with manufacturing facilities that follow cGMP guidelines in the USA, Japan, and the Netherlands, and a media optimization center in China. All sites prioritize strategies that adhere to the FUJIFILM Sustainability Value Plan 2030 for sustainable growth. FUJIFILM Irvine Scientific, Inc. is a subsidiary of FUJIFILM Holdings America Corporation reporting to FUJIFILM Holdings Corporation.

We are hiring a QC Labware System Admin. The QC Labware System Admin will be responsible for the effective provisioning, configuration, operation, updating and maintenance of the LabWare system.

External US

Responsibilities

• Configure and maintain installations
• Troubleshoot process failures and implement process improvement
• Proactively follow up on support issues for timely resolution
• Work with vendor and internal team members to validate and apply version upgrades
• Use efficient programing techniques to produce QC derived datasets tables, figures, and data listings.
• Work with process owners to deploy new modules, provide advanced training to process owners, streamline or make the process more efficient
• Assist Quality Control with issues or sample processing as needed
• Cross- support of other global labs on implementation of the LabWare
• Other duties as assigned

Required Skills/Education

• High school diploma or equivalent.
• A minimum of two (2) years’ experience as an analyst/administrator for an electronic lab information management system in a pharmaceutical or medical device company
• A minimum of two (2) years’ experience work with or on with LabWare
• Experience with interfacing instruments with LabWare
• Computer skills, specifically MS Word, Excel, Adobe Acrobat.
• Current industry regulations, i.e. 21 CFR Part 11,21 CFR Part 820, ISO 13485, EU Annex 11
• Ability to speak, write and read English.
• Good oral and written communication skills.

Salary and Benefits:

• For California, the base salary range for this position is $61,594.00 to $79,954.00 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

EEO/AGENCY NOTES

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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