Job Description
* On - site, contract position in Santa Ana, CA!
· 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. 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.
Requirements :
· 1 year of biotech, medical device, pharmaceutical industry experience
· 1 year of batch records experience
· High school diploma or GED
· Strong computer skills
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