Quality Assurance(QA) Operations Associate (GMP)
Novartis, Millburn, NJ, United States
Quality Assurance (QA) Operations Associate
Our QA Operations Associate manages Quality aspects and projects within the area of responsibility, ensuring overall GxP conformity and compliance with the Novartis Quality Management Systems for the Millburn manufacturing site.
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, and ensure timely escalation to management of all applicable incidents.
Support 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 elevate 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.
Experience: 2+ years in GxP (Bio)pharmaceutical or API manufacturing operations.
Experience: 1+ year in a quality assurance role preferred.
Collaborating across boundaries.
Functional Breadth: QA and/or QC experience in pharmaceutical industry with environmental monitoring & cleanliness zones.
Additional Information
Location: Millburn, NJ (Onsite).
Shift: Week 1: Sun-Wed AM (6:00am‑5:30pm) / Week 2: Sun-Tue AM (6:00am‑6:30pm).
Pay Rate: $25/Hour - $28.35/hour based on experience and qualifications (W2 Only).
Contract: 12-month.
Health, dental, vision, 401k.
Worker flexibility: 36‑42 hours; personnel required to wear PPE such as lab coat, hairnet, beardnet, coveralls, hood, booties.
Why Novartis
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?
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.
Accommodation
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to Magnit at directsourceproteam@prounlimited.com.
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Our QA Operations Associate manages Quality aspects and projects within the area of responsibility, ensuring overall GxP conformity and compliance with the Novartis Quality Management Systems for the Millburn manufacturing site.
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, and ensure timely escalation to management of all applicable incidents.
Support 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 elevate 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.
Experience: 2+ years in GxP (Bio)pharmaceutical or API manufacturing operations.
Experience: 1+ year in a quality assurance role preferred.
Collaborating across boundaries.
Functional Breadth: QA and/or QC experience in pharmaceutical industry with environmental monitoring & cleanliness zones.
Additional Information
Location: Millburn, NJ (Onsite).
Shift: Week 1: Sun-Wed AM (6:00am‑5:30pm) / Week 2: Sun-Tue AM (6:00am‑6:30pm).
Pay Rate: $25/Hour - $28.35/hour based on experience and qualifications (W2 Only).
Contract: 12-month.
Health, dental, vision, 401k.
Worker flexibility: 36‑42 hours; personnel required to wear PPE such as lab coat, hairnet, beardnet, coveralls, hood, booties.
Why Novartis
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?
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.
Accommodation
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to Magnit at directsourceproteam@prounlimited.com.
#J-18808-Ljbffr