Supervisor, QA Release
Novartis - Emeryville, CA

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Responsible for review and product release decision activities pertaining to Novartis Immunodiagnostics products used at the Emeryville site. Registered with FDA as Lot Release Authority. Areas of responsibility include technical review of batch records and lot release activities, discrepancy resolution. Implement, maintain and/or improve the existing release process to meet or exceed regulatory compliance and ISO requirements. Lead a team of MQA Technical Reviewers. Supervise the review and release process of Intermediates/Peptides/Antigens. Develop a cohesive and effective team that works together to achieve defined service Provide leadership, training, positive and constructive feedback to QA reviewers Perform batch record review to ensure compliance, accuracy, completeness, and accountability, and product disposition to support releases. Oversee Real time Record Review program. Registered with FDA as lot release authority for immunodiagnostics products. Represent MQA release at operational and cross-functional meetings Understand and provide input regarding appropriate regulations and quality standards. Assist in investigations to ensure that the corrective and preventive actions address the root cause. Create and/or review and approve SOPs, BPRs to assure that they are designed to facilitate ‘first time quality’ and compliance with cGMPs Optimizes department procedures to improve efficiency, whenever possible. Evaluate impact of proposed changes on MQA release processes and documentation. Support audit and inspection activities, as needed. Participate in Failure Mode and Effect Analysis (FMEA) and Operational Quality Risk Assessment processes. Ensure adherence to current Good Manufacturing Practices. Participate in departmental projects and provide assistance in other areas, as needed.

Minimum requirements
BS/BA degree, preferably in a scientific discipline. Minimum 5-7 years of cGMP/QA/Product Release experience in a medical device, biotech, or pharmaceutical company Thorough knowledge and understanding of cGMPs/QSRs/ISO Proficiency in computer skills (Trackwise and/or Livelink experience desirable) Strong attention to detail Thorough knowledge of Product Release Good communication skills Ability to coordinate multiple projects and complete deliverables within expected timelines Minimum 5-7 years of cGMP/QA/Product Release experience in a medical device, biotech, or pharmaceutical company Thorough knowledge and understanding of cGMPs/QSRs/ISO Proficiency in computer skills (Trackwise and/or Livelink experience desirable) Strong attention to detail Thorough knowledge of Product Release Good communication skills Ability to coordinate multiple projects and complete deliverables within expected timelines

Novartis - 8 months ago - save job - block
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About this company
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Novartis AG, incorporated on February 29, 1996, is a Switzerland-based holding that, through its subsidiaries, is engaged in the research,...