Production Clerk

FUJIFILM Electronic Materials U.S.A., Inc.; Irvine (CA); On-site; USD 28,000 - 36,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life Insurance

401k

Paid Time Off

Job summary

FUJIFILM Biosciences in California is seeking a Production Clerk responsible for maintaining production documents, ensuring accuracy to comply with cGMP and GDP guidelines, and reviewing batch records before submission to QC. The role requires 1 year of manufacturing/quality experience and ERP proficiency.

The first shift runs 8:00 am–5:00 pm and candidates must read and write English, with strong communication skills. Benefits include medical, dental, vision, life insurance, 401k, and PTO.

Qualifications

• High school diploma or equivalent; some postsecondary education desirable.
• 1 year of manufacturing/quality experience in bioscience, pharmaceutical or medical devices.
• Knowledge of GMP, GDP, ISO, FDA and OSHA regulatory requirements.
• Working experience with ERP systems.
• Knowledge of batch records including GMP and GDP rules.
• Proficiency in MS Office Suite.
• Knowledge of the metric system.
• Experience weighing materials and measuring volume in a manufacturing environment.
• Ability to learn processing methods compliant with GMPs.
• Ability to read and speak English.
• Good oral and written communication skills.

Responsibilities

• Examines batch record documentation to assess completeness, accuracy, and conformance to cGMP and GDP standards and company policies.
• Navigate ERP to complete electronic folder reviews and confirm inventory adjustments are transacted appropriately; maintains DPR data.
• Track errors and work with Production management to eliminate recurrences.
• Update material issuances in the ERP system for raw materials used during production.
• Other duties, as assigned.

Skills

GMP GDP knowledge

Batch records knowledge

English proficiency

Communication skills

ERP systems experience

Education

High school diploma or equivalent

Postsecondary coursework desirable

Tools

ERP system

MS Office Suite

Job description

Position Overview

The Production clerk will be responsible for the maintenance and flow of Production documents as well as monitoring the accuracy and completeness to ensure compliance with cGMP and GDP guidelines and company policies. They will also review the batch records before submission to QC by ensuring that the documentation is free of errors is a key function of this position.

First Shift: 8:00 am- 5 pm

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:

• Examines batch record documentation and materials issuances, in order to assess completeness, accuracy, and conformance to cGMP and GDP standards and company policies.
• Able to navigate proficiently in ERP system to complete electronic folder reviews and confirm inventory adjustments are transacted appropriately. Maintains and records production data in the Daily Production Record (DPR) file including units produced, in-process rejects, QC samples, etc.
• While reviewing the batch record, tracks types of errors by the technicians, and works closely with Production management and technicians to eliminate reoccurrences.
• Update material issuances in the ERP system for the raw materials/components used during production.
• Other duties, as assigned.

Required Skills/Education:

• High school diploma or equivalent. Some post high school education is desirable.
• 1 Year Previous Manufacturing / Quality experience in bioscience, pharmaceutical or medical devices industry.
• Working knowledge of GMP, GDP, ISO, FDA and OSHA regulatory requirements.
• Working experience with ERP system.
• Working knowledge of batch records including GMP and GDP rules governing their accuracy and completeness.
• Knowledge of using computers and proficiency in MS Office Suite.
• Knowledge of Metric System.
• Knowledge of weighing of materials and measuring volume in a manufacturing environment.
• Ability to learn processing methods that comply with current Good Manufacturing Practices (GMPs).
• Ability to speak and read English.
• Good oral and written communication skills.

Salary and Benefits:

• For California, the base salary range for this position is $20.24 - $26.28 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 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 pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([e-mail]).