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Specialist, QA Lot Release (Temporary) Novato United States,  

Posted on : 07 May 2017

Project Description

BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind. Inspection, Review and Disposition of raw material lot files per BioMarin SOPsEnter raw material lot disposition in LIMS and other databases, as applicableMaintain electronic status control for cGMP raw materialsUnderstand the Materials Management and QC raw materials procedures to ensure raw material lot files are compliant with these systems.Provide QA verification of transfer of FBDS from Manufacturing to Quarantine storagePerform QA approval of OWK pre-weight kitsPerform QA inspection of primary packaging componentsProvide QA support to other QA raw materials activities: BioMarin reserve sample program, in-house label production, control of rejected materials, and in-process materials returned from contract sites.Attention to detail, organized, ability to work independently with minimal supervision. Primary job function is documentation review, both paper and computer documents. Familiarity with Microsoft Office PC, experience with LIMS or other similar databases a plus.0-4 years previous experience in a GMP environment.Bachelor of Science degree in Biology, Biochemistry, Chemistry or related field#LI-DNI We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.


Novato, California

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