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 Quality Product Release Coordinator.  The Quality Product release coordinator ensures quality of product by performing reviews of batch folder documentation in order to release product.  Creates and signs off all Certificate of Analysis.  Responsible for return goods authorization product verification. 

Responsibilities

• Review and verify all documentation in the batch record and maintain database for the QA Final Release History.
• Creates and maintains database for Certificate of Analysis
• Review and process Return Good Authorizations
• Inspect labeling and storage conditions of product
• Maintain the non-conforming material log, files and database
• Assist in the preparation of all controlled documents (generating DCRs as needed)
• Reviews and improves processes as needed (provides training as needed)
• Maintains Device History Records files and database
• Performs internal audits as needed
• Assist Document Control department as needed
• Collaborates with other departments to meet customer requests
• Lot folder scanning
• Other duties may be assigned
• Full time, onsite, M-F 7-4:30 with schedule flexibility.

Required Skills/Education 

• High school diploma or equivalent; basic understanding of mathematics and chemistry.

• A minimum of two (2) years of Quality Assurance in medical device manufacturer or equivalent.

• Proficiency in current versions of WordPerfect, MS Word, Excel, Outlook

• Computer skills 
• Ability to speak, read, and write English.
• Good verbal and written communication skills

Preferred 

• Two years of college in a science discipline is preferred.
• Knowledge of SAP or equivalent ERP system (Oracle, etc.)

Salary and Benefits:

• For California, the base salary range for this position is $24.20 to $31.32 an hour. 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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