QA Operations Specialist- 2nd shift - Novartis
Millburn, NJ
About the Job
Quality Assurance (QA) Operations Specialist
Location: Millburn, NJ #LI-Onsite
At Advanced Accelerator Applications, a Novartis company, we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy to cancer patients. We are looking for experienced QA professionals to help us reach our ambitious goals.
The Quality Assurance Specialist will be responsible for supporting oversight of manufacturing, testing and supply chain operations to ensure compliance with current GMP regulations and the Novartis SOP's and systems.
Overall duties:
o Provide QA support of production, engineering, and supply chain operations through review/approval of test records for batch release, SOPs, CAPAs, Deviations, change controls, and shop floor oversight. Provides the production, engineering, and supply chain teams with QA/Compliance guidance and decisions.
o Review and approve Standard Operating Procedures, Quality Risk Assessments, Quality Plans related to manufacturing operations, as needed. Contribute to generation of Annual Product Reviews for production, engineering and supply chain.
o Support continuous quality improvement program for manufacturing operations and partner with the production, engineering, and supply chain teams to implement/optimizes to improve efficiency and monitor/escalate as needed.
o Supports all regulatory inspections related to preparedness initiatives and executions of the inspections.
o Provide cGMP and associated OJT training to any other quality members and other operational areas as needed.
o Perform or support any other tasks necessary to maintain the product quality and site cGMP compliance, as needed.
When hired, you will focus on Shop Floor OR Batch Release specific responsibilities:
• Shop floor oversight:
o Supports QA Operations programs especially related to batch release activities and shop floor programs which includes Visual Monitoring on Surprise, GEMBA walkthrough program, equipment/area/utility out of service program, QA area release of classified and unclassified areas, QA media fill oversight programs, event triage and support of routine operations.
o Assist in triaging when an event or issue arises during manufacturing operations
• Batch Record Review and Release:
o Review/approve investigations of excursions in production, engineering, and supply chain operations. Support resolution of major and critical quality events, monitor that recurrent events are properly escalated and resolved. Ensure root cause is determined, evaluate impact on product quality, disposition, and corrective actions.
o Perform final review of production data test data/reports to ensure conformance to the established specifications and standard operating procedures. Act as Responsible Person for the final disposition of products.
o Follow the scheduling of tasks set forth by the QA operations Lead or Head for batch record issuance and record review and release activities
NOTE: This is a 2nd shift position
Location: Millburn, NJ #LI-Onsite
At Advanced Accelerator Applications, a Novartis company, we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy to cancer patients. We are looking for experienced QA professionals to help us reach our ambitious goals.
The Quality Assurance Specialist will be responsible for supporting oversight of manufacturing, testing and supply chain operations to ensure compliance with current GMP regulations and the Novartis SOP's and systems.
Overall duties:
o Provide QA support of production, engineering, and supply chain operations through review/approval of test records for batch release, SOPs, CAPAs, Deviations, change controls, and shop floor oversight. Provides the production, engineering, and supply chain teams with QA/Compliance guidance and decisions.
o Review and approve Standard Operating Procedures, Quality Risk Assessments, Quality Plans related to manufacturing operations, as needed. Contribute to generation of Annual Product Reviews for production, engineering and supply chain.
o Support continuous quality improvement program for manufacturing operations and partner with the production, engineering, and supply chain teams to implement/optimizes to improve efficiency and monitor/escalate as needed.
o Supports all regulatory inspections related to preparedness initiatives and executions of the inspections.
o Provide cGMP and associated OJT training to any other quality members and other operational areas as needed.
o Perform or support any other tasks necessary to maintain the product quality and site cGMP compliance, as needed.
When hired, you will focus on Shop Floor OR Batch Release specific responsibilities:
• Shop floor oversight:
o Supports QA Operations programs especially related to batch release activities and shop floor programs which includes Visual Monitoring on Surprise, GEMBA walkthrough program, equipment/area/utility out of service program, QA area release of classified and unclassified areas, QA media fill oversight programs, event triage and support of routine operations.
o Assist in triaging when an event or issue arises during manufacturing operations
• Batch Record Review and Release:
o Review/approve investigations of excursions in production, engineering, and supply chain operations. Support resolution of major and critical quality events, monitor that recurrent events are properly escalated and resolved. Ensure root cause is determined, evaluate impact on product quality, disposition, and corrective actions.
o Perform final review of production data test data/reports to ensure conformance to the established specifications and standard operating procedures. Act as Responsible Person for the final disposition of products.
o Follow the scheduling of tasks set forth by the QA operations Lead or Head for batch record issuance and record review and release activities
NOTE: This is a 2nd shift position
Source : Novartis