FUJIFILM Irvine Scientific, Inc. is 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 review batch records before submission to QC by ensuring that the documentation is free of errors is a key function of this position.
FUJIFILM Irvine Scientific, Inc. is a global leader in the innovation and manufacture of cell culture solutions for Life Science and Medical markets, providing products and services that assist customers in advancing healthcare initiatives. Working across discovery research, cell and gene therapy, reproductive medicine and cytogenetics, as well as the large-scale production of biotherapeutics and vaccines, the Company is trusted by researchers, manufacturers, and clinicians worldwide. For over 50 years, FUJIFILM Irvine Scientific’s Mission has been to empower all who bring medicines and treatments to life with unmatched quality and responsiveness in its products and custom solutions, providing customers with the vital resources needed to enrich human lives through innovative, accessible therapies. The Company’s facilities adhere to both ISO and FDA regulations, with manufacturing facilities that follow cGMP guidelines in the USA, Japan, and the Netherlands, and a media optimization center in China. All sites prioritize strategies that adhere to the FUJIFILM Sustainability Value Plan 2030 for sustainable growth. FUJIFILM Irvine Scientific, Inc. is a subsidiary of FUJIFILM Holdings America Corporation reporting to FUJIFILM Holdings Corporation.
External US
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. One year previous Manufacturing and 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 in English.Good oral and written communication skills.
Salary and Benefits:
For California, the base hourly range for this position is $19.08 - $24.77 per hour. Compensation for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience, location, etc.).Medical, Dental, VisionLife Insurance401kPaid Time Off
EEO/AGENCY NOTES
Fujifilm is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (includes pregnancy, childbirth, breastfeeding and related medical conditions), and sexual orientation, and any other status protected by federal, state, or local law.
To all agencies: Please, no phone calls or emails to any employee of Fujifilm about this requisition. All resumes submitted by search firms/employment agencies to any employee at Fujifilm via-email, the internet or in any form and/or method will be deemed the sole property of Fujifilm, unless such search firms/employment agencies were engaged by Fujifilm for this requisition and a valid agreement with Fujifilm is in place. In the event a candidate who was submitted outside of the Fujifilm agency engagement process is hired, no fee or payment of any kind will be paid.
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