This position will be located at Morris Plains, NJ and will not have the ability to be located remotely.

The Quality Assurance Specialist is responsible for first level, hands on, day-to-day cGMP facilitator role for all site related GMP activities. They interact directly with site staff, who are performing the daily operational functions, Make, test, Release, in support of their effort to produce quality products. This role ensures that the quality strategy is implemented and that there is a continuous drive to improve product and process quality within the PU, QC labs, and other support areas.

#LI-Onsite

Key Responsibilities:
• Shopfloor Activities: Conduct routine shop floor tasks related to aseptic operations including but not limited to ViMOS, APV observations, walkthroughs, QA area release, and, QC Floor support, etc.
• Perform triaging of events on shopfloor for PU and QC laboratories as well as other support areas, ensuring that deviations records are initiated adequately in deviation management system.
• Review Activities: Review and audit production batch records, and/or QC related documentation, to ensure adherence to Novartis policies, SOPs, and cGMP requirements.
• Interface closely with PU and QC to assist with batch record/QC data review, release, and compliance issue resolution.
• Actively participate in process improvement initiatives aiming for Right First Time (RFT) on documentation and deviation reduction.
• Ensures levels of documentation are adequate and compliant to existing procedures.
• Write, review and approve Standard Operating Procedures (SOPs), Work Procedures (WPs), and Forms (FRMs), as needed.
• Release Activities: ensure timely review and release of Aphs and media batches, Area release, and related activities.
• Responsible for the PP/ FP final release of patient product ensuring timely and robust product disposition in accordance with GMP and license requirements. Ensure the Disposition process meets industry and Novartis expectations and requirements