Description

Job Description Summary
Help 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.

Our QA Operations Associate 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 Millburn manufacturing site.

Location: Millburn #LI-Onsite
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Shift:
Week 1: Sun-Wed AM (6:00am-5:30pm)
Week 2: Sun-Tue AM (6:00am-6:30pm)

Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

Job Description

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.

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range
$60,600.00 - $112,600.00

Skills Desired
Collaboration, Communication Skills, Data Integrity, Dealing With Ambiguity, Digital saviness, Leadership, Operational Excellence, Problem Solving Skills, Regulatory Requirements knowledge