QA Operations Associate

Key Responsibilities:

• Provide shopfloor quality oversight of all production, quality control and supply chain departments to ensure their practice fully adheres to cGMP, including data integrity. Ensure timely escalation to management of all applicable incidents.
• Supports QA Operations programs especially related to batch release activities and shop floor programs which includes Visual Monitoring on Surprise (ViMOS), 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.
• Assist functional areas with achieving timely and compliant raw material disposition and ensure compliance of site personnel according to current procedures and GMP requirements
• Oversight of Final Product dose storage once all manufacturing activities are completed.
• Perform Facility Alarm review and assess the impact of each alarm. Escalate any GxP impact immediately
• Perform live review of manufacturing/packaging batch records in preparation for batch release and escalate any discrepancies immediately.
• Support FDA/Regulatory interactions for the Millburn RLT Site products to ensure successful regulatory submissions and inspections.
• Support QA Operations as a valued business partner, with a culture of safety, quality, delivery to patients, cost, compliance and data integrity.
• Support continuous quality improvement program for manufacturing operations and partner with the production, engineering, and supply chain teams to implement/optimizes to improve efficiency (right the first time) and monitor/escalate as needed.

Essential Requirements

Education: Bachelors' Degree, preferably in Life Sciences, Chemistry or related relevant degree preferred.  In lieu of degree, 3-5 years in a role within pharma industry that includes quality assurance experience will be considered

• 2+ years of experience in a GxP (Bio)pharmaceutical or API manufacturing operations
• 1+ years of experience in a quality assurance role preferred
• Collaborating across boundaries
• Functional Breadth
• QA and/or QC experience in pharmaceutical industry with environmental monitoring & cleanliness zones

The salary for this position is expected to range between $29.13 and $54.13/hour. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.

US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.