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Remote Quality Assurance Senior Manager

Company: VirtualVocations
Location: Lowell
Posted on: May 7, 2021

Job Description:

A company dedicated to development of gene therapies is seeking a Remote Quality Assurance Senior Manager. Core Responsibilities of this position include: Reviewing and approving master batch records, master labeling/packaging records, product specifications and other process related documents from contract sites Performing batch release through batch record and data review/approval and managing process deviations for timely release Reviewing and/or approving deviations, OOS, CAPAs, change control in an efficient manner for adequate and timely closeout of these events Qualifications Include: Working knowledge of US CGMPs Extensive experience in the pharmaceutical/bio-pharm manufacturing industry with prior experience at the QA Manager level Experience working with Quality systems in support of both early and late stage development programs Relevant equivalent content experience, including managing contract manufacturers and external vendors In depth working knowledge of cGMPs, ICH guidelines and applicable EU/US regulatory requirements for biological products BSc or higher degree in biology, biochemistry, or other relevant scientific discipline

Keywords: VirtualVocations, Lowell , Remote Quality Assurance Senior Manager, Executive , Lowell, Massachusetts

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