Sentences with phrase «batch record audits»
Performed manufacturing Batch Record Audits for compliance to manufacturing process, procedures, and company procedure for completeness and accuracy prior to product release, reject and or lot closure.
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Conduct internal audits, supplier / contract (3rd party) manufacturer audits, and allograft (batch record) file reviews.
Tags for this Online Resume: QA, Audits, GMP, FDA, Quality, Compliance, ELISA, Manufacturing, Therapy, Cancer, oncology, pharmaceutical, Batch Record, Immunotherapy, Drug product, Drug substance
Merck & Co. / Schering Plough Research Institute (Summit, NJ) 2003 — 2004 Scientist I • Managed quality control, batch record review, compliance audits, and data automation • Identified batch errors and instigated corrective measures while increasing efficiency • Oversaw national and international legal compliance ensuring professional operations • Designed, developed, and implemented electronic specification application • Utilized data automation which enhanced compliance and cut calculation time by 70 %