Novartis
QAOperationsSpecialist
Neural analysis suggests this role is
optimal for Mid+ candidates.
“QA Operations Specialist at Novartis. Skills: Quality Assurance, GxP, cGMP, Batch Release, Compliance. Provide QA support of production, QC, engineering, and supply chain operations through review/approval of test records for batch release, SOPs, CAPAs, Deviations, OOX investigations, Quality Risk Assessments, Quality Plans/Events, protocols, and change controls.. Provide shop floor oversight with QA/compliance guidance to support decision-making throughout these processes.”
What You'll Achieve.
ensuring and supporting overall GxP conformity and Compliance with the Novartis Quality Management Systems for the Indianapolis manufacturing site.; enhance efficiency; ensure product quality; maintain site cGMP compliance
Industry & Context.
shift work, 12-hour shifts, weekends will be required
What They're Looking For.
Must Have
Bachelors' Degree, 3+ years of experience in a GxP (Bio)pharmaceutical or API manufacturing operations, 2+ years of experience in a quality assurance role, QA and/or QC experience in pharmaceutical industry with environmental monitoring & cleanliness zones, Knowledge of FDA and EU regulations and experience in US and international regulatory agency inspections
Nice to Have
preferably in Life Sciences, Chemistry or related relevant degree
What You'll Do.
Provide QA support of production
and supply chain operations through review/approval of test records for batch release
Quality Risk Assessments
Provide shop floor oversight with QA/compliance guidance to support decision-making throughout these processes.
Manufacturing support includes live batch record review and execution of AQL inspections.
Support continuous quality improvement initiatives for manufacturing operations by collaborating with production
and supply chain teams to implement and optimize processes that enhance efficiency.
Support all regulatory inspections by assisting with preparedness initiatives and executing inspection activities
while also continuously performing/supporting any tasks necessary to ensure product quality and maintain site cGMP compliance as needed.
Provide cGMP and associated OJT training to any other quality members and other operational areas as needed.
Perform Master Batch Record approvals and issuance of batch records and labels
Perform Raw Materials release
updating statuses of materials in the ERP system.
Reviewing and approving raw material documentation and supplier CoAs to ensure quality and compliance of raw materials to be used in manufacturing processes.
Perform Final Batch Record Review and Final Product Release
Perform a comprehensive review of all executed batch records and associated documentation to ensure compliance with specifications and regulatory requirements before product release.
Support the following programs as needed: Change Control Management
Customer Complaint Management
Document Control Management
Training Program Management
Supplier Qualification Program
Audit/Self-Inspection Program
Annual Product Quality Review (APQR)
How You'll Work.
Team & Collaboration
collaborating with production, QC, engineering, and supply chain teams; Collaborating across boundaries
Process & Methodology
Quality aspects and projects within area of responsibility
Full Job Description
**Band** Level 3 **Job Description Summary** About this role: Help reimagine cancer care by shaping how our Radioligand Therapies (RLT) reach more patients—safely, reliably, and faster. At Novartis, we’re pioneering the future of treatment through the fusion of nuclear medicine and precision oncology. Our QA Operations Specialist manages Quality aspects and projects within area of responsibility as well as ensuring and supporting overall GxP conformity and Compliance with the Novartis Quality Management Systems for the Indianapolis manufacturing site. Location: Carlsbad, CA #LI-Onsite Shift: This position involves shift work which will be defined through site start up and commercialization readiness. 12-hour shifts and weekends will be required. **Job Description** **Key Responsibilities:** * Provide QA support of production, QC, engineering, and supply chain operations through review/approval of test records for batch release, SOPs, CAPAs, Deviations, OOX investigations, Quality Risk Assessments, Quality Plans/Events, protocols, and change controls. Additionally, provide shop floor oversight with QA/compliance guidance to support decision-making throughout these processes. * Manufacturing support includes live batch record review and execution of AQL inspections. * Support continuous quality improvement initiatives for manufacturing operations by collaborating with production, QC, engineering, and supply chain teams to implement and optimize processes that enhance efficiency. * Support all regulatory inspections by assisting with preparedness initiatives and executing inspection activities, while also continuously performing/supporting any tasks necessary to ensure product quality and maintain site cGMP compliance as needed. * Provide cGMP and associated OJT training to any other quality members and other operational areas as needed. **Cross Train Expectations:** **QA Batch Release:** * Perform Master Batch Record approvals and issuance of batch records and labels
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