QA Product Release Coordinator I

Fujifilm; Santa Ana (CA); Vor Ort; USD 53.000 - 60.000; Vollzeit

Benefits dieser Stelle

Medical, Dental, Vision

401k

Paid Time Off

Zusammenfassung

FUJIFILM Biosciences in Santa Ana, CA is seeking a Product Release Coordinator to ensure product quality through batch folder documentation reviews and to sign off on Certificate of Analysis. The role includes handling Return Goods Authorizations and maintaining QA records.

You will collaborate with QA and manufacturing teams to verify labeling, storage conditions, and compliance with 21 CFR210/211 etc. The position emphasizes accuracy, documentation control, and timely releases.

Qualifikationen

• High school diploma or equivalent.
• Basic math and chemistry understanding required.
• Two years of college in a science discipline preferred.
• Minimum two years of QA in medical device manufacturing or equivalent.
• Proficient with WordPerfect, MS Word, Excel, and Outlook.
• Must speak, read, and write English.

Aufgaben

• Review and verify batch documentation and maintain QA history.
• Create and maintain database for Certificate of Analysis.
• Process Return Goods Authorizations.
• Inspect labeling and storage conditions.
• Maintain the non-conforming material log and files.
• Assist in preparing controlled documents.
• Support internal audits and cross-department collaboration.
• Lot folder scanning.

Kenntnisse

Quality assurance

English proficiency

Chemistry knowledge

Software proficiency

Ausbildung

High school diploma or equivalent

Two years of college in science

Tools

WordPerfect

MS Word

Excel

Outlook

Jobbeschreibung

Position Overview

We are hiring a Product Release Coordinator. The Product Release Coordinator will ensure quality of product by performing reviews of batch folder documentation in order to release product. They will also create and sign off all Certificate of Analysis and are responsible for return goods authorization product verification.

Company Overview

At 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 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.” Visit: https://www.fujifilm.com/us/en/about/region/careers

Job Description

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

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




• Computer skills




• Current industry regulations, i.e. Detailed understanding of: 21CFR211-cGMP, 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 salary range for this position is $25.68 - $29.00 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

*#LI-onsite

EEO Information

Fujifilm is committed to 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 pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([e-mail]).