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 with cGMP and GDP guidelines and company policies. Review of batch records before submission to QC by ensuring that the documentation is free of errors is a key function of this position.
- 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
- 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
For California, the base salary range for this position is $18.52 to $29.58 hourly. Compensation for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience, location, etc.).
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.