Product Release Coordinator I- Quality Assurance

FUJIFILM Biosciences; Santa Ana (CA); On-site; USD 35,000 - 40,000; Full time

Benefits offered by this job

Medical, Dental, Vision

Life Insurance

401k

Paid Time Off

Job summary

FUJIFILM Biosciences in Santa Ana, CA is hiring a Product Release Coordinator responsible for ensuring product quality by reviewing batch folder documentation and releasing products after sign-off. You will create and sign off Certificates of Analysis, manage Return Goods Authorizations, and maintain compliant device history records while collaborating with QA and regulatory teams.

The ideal candidate has attention to detail, familiarity with 21 CFR parts and ISO quality standards, and

Qualifications

• Must have strong attention to detail and ability to maintain accurate documentation.
• Experience with QA in medical device industry or equivalent preferred.
• Familiarity with regulatory requirements (FDA, ISO) and batch documentation practices.

Responsibilities

• Review batch records and maintain QA Final Release History database.
• Create and maintain Certificate of Analysis records.
• Process Return Goods Authorizations and inspect labeling/storage conditions.
• Maintain non-conforming material logs and controlled document systems.
• Assist in preparing controlled documents and training as needed.
• Collaborate with other departments to fulfill customer requests.
• Assist Device History Records files and internal audits as required.
• Support Document Control and process improvements.

Skills

Attention to detail

Quality mindset

Communication skills

Problem solving

Education

High school diploma or equivalent

Two years of college in a science discipline

Two years of Quality Assurance in medical device manufacturer or equivalent

Tools

WordPerfect

MS Word

Excel

Outlook

Job description

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

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]).