Product Release Coordinator I
Product Release Coordinator I
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Job Description
Position Overview
We are hiring a Product Release Coordinator. The Product Release Coordinator will be responsible for ensuring quality of product by performing reviews of batch folder documentation in order to release product. They will create and sign off all Certificate of Analysis and be responsible for returned goods authorization product verification.
Company Overview
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 assistcustomers in advancing healthcare initiatives. Working across discovery research cell and gene therapy reproductive medicineand cytogenetics as well as the largescale production of biotherapeutics and vaccines the Company istrusted by researchers manufacturers and over 50 years FUJIFILM Irvine ScientificsMission has been to empower all who bring medicines and treatments to life with unmatched quality and responsiveness in itsproducts and custom solutions providing customers with the vital resources needed to enrich human lives through innovative accessible therapies. The Companysfacilities 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 centerin China. All sites prioritize strategies that adhere to the FUJIFILM Sustainability ValuePlan 2030 for sustainable growth. FUJIFILM Irvine Scientific Inc. is a subsidiary of FUJIFILM Holdings America Corporation reporting to FUJIFILM Holdings Corporation.
Job Description
Responsibilities
- Creates and maintains database for Certificate of Analysis
- Inspect labeling and storage conditions of product
- 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
- Assist Document Control department as needed
- Collaborates with other departments to meet customer requests
- Lot folder scanning
Required Skills/Education
- High school diploma or equivalent; basic understanding of mathematics and chemistry necessary
- Two years of college in a science discipline is preferred
- 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 and an MRP system
- Computer skills
- Current industry regulations i.e. Detailed understanding of 21CFR211cGMP FDA QSR 820 ISO13485:2003 Canadian Medical Device Regulations and inspection and auditing guidelines
- Ability to speak read and write English
- Good Oral and communication skills
Salary and Benefits:
- For California the base hourly range for this position is $24.93 $32.26 per 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
*#LIonsite
EEO Information
Fujifilm is committedto 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.
ADA Information
If you require reasonable accommodation in completing this application interviewing completing any preemployment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department ().
Required Experience:
IC
Employment Type
Unclear
