Quality Assurance Product Release Coordinator I

Merck & Co.; Santa Ana (CA); On-site; USD 53,000 - 60,000; Full time

Benefits offered by this job

Medical, Dental, Vision

Life Insurance

401k

Paid Time Off

Job summary

Fujifilm Biosciences in Santa Ana, CA seeks a Product Release Coordinator to ensure product quality by reviewing batch documentation and signing off on Certificates of Analysis. The role includes return goods verification, labeling inspection, and maintaining QA records to support compliant release.

The candidate will work with cross-functional teams, perform internal audits, and assist in controlled document preparation.

Qualifications

• Must have QA experience in medical device manufacturing or equivalent.
• Strong understanding of regulatory requirements and quality systems.
• Ability to read, write and communicate in English clearly.

Responsibilities

• Review batch records and maintain the QA Final Release History database.
• Create and maintain the Certificate of Analysis database.
• Process Return Goods Authorizations and inspect labeling and storage.
• Maintain non-conforming material logs and file databases.
• Assist in preparing controlled documents and training staff as needed.
• Support internal audits and collaborate with other departments to meet customer requests.
• Manage Device History Records and perform routine document control tasks.

Skills

Quality Assurance

Regulatory knowledge

English writing and reading

Communication skills

Attention to detail

Education

High school diploma or equivalent

Two years of college in a science discipline is preferred

Tools

WordPerfect

MS Word

Excel

Outlook

Job description

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 scrolling

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]).