Quality Assurance(QA) Operations Associate (GMP)
WillHire, Millburn, NJ, United States
Quality Assurance (QA) Operations Associate
About this role:
Our QA Operations Associate manages Quality aspects and projects within the area of responsibility and ensures 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 full adherence to cGMP, including data integrity.
Ensure timely escalation to management of all applicable incidents.
Support QA Operations programs related to batch release activities and shop floor programs including 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 routine operations.
Assist functional areas with timely and compliant raw material disposition and ensure compliance of site personnel per current procedures and GMP requirements.
Oversee Final Product dose storage once all manufacturing activities are completed.
Perform facility alarm review and assess the impact of each alarm; escape any GxP impact immediately.
Perform live review of manufacturing/packaging batch records for batch release and immediately address discrepancies.
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, embodying a culture of safety, quality, delivery to patients, cost control, compliance, and data integrity.
Support continuous quality improvement program for manufacturing operations and partner with production, engineering, and supply chain teams to implement or optimize processes to improve efficiency and monitor/escalate as needed.
Essential Requirements
Education:
Bachelor’s Degree, preferably in Life Sciences, Chemistry or a related field.
Experience:
2+ years in a GxP (Biopharmaceutical or API) manufacturing operations; 1+ year in a quality assurance role preferred.
Collaboration across boundaries and functional breadth.
QA and/or QC experience in the pharmaceutical industry with environmental monitoring & cleanliness zones.
Must be flexible with shift schedule and wear PPE such as lab coat, hairnet, beardnet, coveralls, hood, booties.
Location
Millburn, NJ (Onsite)
Shift
Week 1: Sun‑Wed AM (6:00 am‑5:30 pm)
Week 2: Sun‑Tue AM (6:00 am‑6:30 pm)
Compensation
Pay Rate: $25 / hour – $28.35 / hour based on experience and qualifications (W2 Only)
Contract
12‑month
Benefits
Health, dental, vision, 401k
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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About this role:
Our QA Operations Associate manages Quality aspects and projects within the area of responsibility and ensures 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 full adherence to cGMP, including data integrity.
Ensure timely escalation to management of all applicable incidents.
Support QA Operations programs related to batch release activities and shop floor programs including 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 routine operations.
Assist functional areas with timely and compliant raw material disposition and ensure compliance of site personnel per current procedures and GMP requirements.
Oversee Final Product dose storage once all manufacturing activities are completed.
Perform facility alarm review and assess the impact of each alarm; escape any GxP impact immediately.
Perform live review of manufacturing/packaging batch records for batch release and immediately address discrepancies.
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, embodying a culture of safety, quality, delivery to patients, cost control, compliance, and data integrity.
Support continuous quality improvement program for manufacturing operations and partner with production, engineering, and supply chain teams to implement or optimize processes to improve efficiency and monitor/escalate as needed.
Essential Requirements
Education:
Bachelor’s Degree, preferably in Life Sciences, Chemistry or a related field.
Experience:
2+ years in a GxP (Biopharmaceutical or API) manufacturing operations; 1+ year in a quality assurance role preferred.
Collaboration across boundaries and functional breadth.
QA and/or QC experience in the pharmaceutical industry with environmental monitoring & cleanliness zones.
Must be flexible with shift schedule and wear PPE such as lab coat, hairnet, beardnet, coveralls, hood, booties.
Location
Millburn, NJ (Onsite)
Shift
Week 1: Sun‑Wed AM (6:00 am‑5:30 pm)
Week 2: Sun‑Tue AM (6:00 am‑6:30 pm)
Compensation
Pay Rate: $25 / hour – $28.35 / hour based on experience and qualifications (W2 Only)
Contract
12‑month
Benefits
Health, dental, vision, 401k
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