QA Batch Release Specialist

Novartis

United States

United States

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Über

divh2QA Batch Release Specialist/h2pHelp reimagine cancer care by shaping how our Radioligand Therapies (RLT) reach more patientssafely, reliably, and faster. At Novartis, were pioneering the future of treatment through the fusion of nuclear medicine and precision oncology. The QA Batch Release Specialist is responsible for the quality assurance release of radioligand therapy drugs manufactured, packaged and tested in compliance to current GMP regulations, procedures and quality systems. Location: Indianapolis, IN Shift: Night Shift, weekend nights included/ppKey Responsibilities:/pulliPerform release of all manufactured, packaged and tested materials including but not limited to raw materials, intermediates and drug products. Confirm all documentation supporting these releases fully adhere to cGMP, including data integrity. Ensure timely escalation to management of all applicable incidents./liliControlled issuance of batch records in preparation for manufacturing./liliPerform review of manufacturing batch records in preparation for batch release and escalate any discrepancies immediately./liliAssist functional areas with achieving timely and compliant final product disposition of the product./liliEnsure Specifications in place and are within GMP compliance/liliSupport metric tracking of documentation and release data to ensure continuous improvement./liliSupport QA Batch Release as a valued business partner, with a culture of safety, quality, delivery to patients, cost, compliance, and data integrity./liliCAPA management as well as improving processes within QA Batch release/liliOrganize and file all executed and associated GMP documentation (e.g. batch records)./liliMaintain batch documentation library (record check-in, check-out, follow-up, and distribution)/li/ulpEssential Requirements:/pulliBachelors Degree, preferably in Life Sciences, chemistry, or related relevant degree. In lieu of degree, 5 years in a role within pharma industry that includes quality assurance and batch release experience will be considered/lili2+ years of experience in GxP Biopharmaceutical manufacturing operations/lili1+ years of experience in a quality assurance role/liliCross functional collaboration/liliQA and QC experience in biotech pharmaceutical biotechnology industry with environmental monitoring
cleanliness zones is desired/liliProven track record and practical experience with cGMP requirements/liliKnowledge of FDA and EU regulations and experience in US and international regulatory agency inspections./li/ulpSalary Range: $81,200.00 - $150,800.00/ppSkills Desired: Continued Learning, Dealing With Ambiguity, GMP Procedures, QA (Quality Assurance), Quality Control (QC) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence/p/div

United States

Sprachkenntnisse

English

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