Position Description

We are hiring a Production Clerk. 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 batch records before submission to QC by ensuring that the documentation is free of errors is a key function of this position.

At FUJIFILM Irvine Scientific (dba 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 Irvine Scientific (dba 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

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 $19.65- $25.51. 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       

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.

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 (fisihr@fujifilm.com).