What are the responsibilities and job description for the Quality Assurance(QA) Operations Associate (GMP) position at Novartis?
:::Please note: This is a temporary contractor opportunity at Novartis :::
Novartis touches the lives of a tenth of the world’s population. Every role here, regardless of contract type, makes an impact on human life!
Novartis US partners with external managed service provider Magnit Global to offer engaging temporary contractor opportunities like this, to those who are looking for flexibility in their career while looking to gain new skills and experiences providing services to an inclusive global medicines company. Click here to learn more about Magnit www.magnitglobal.com
Ready to work with/through Magnit at Novartis? Please read on...
Quality Assurance( QA) Operations Associate
About this role:
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.
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.
Experience:
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
::Note : Worker has to be flexible with the shift mentioned above as they will be working 36-42 hours and personnel is required to wear PPE such as lab coat, hairnet, beardnet, coveralls, hood, booties. :::
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
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.
Novartis touches the lives of a tenth of the world’s population. Every role here, regardless of contract type, makes an impact on human life!
Novartis US partners with external managed service provider Magnit Global to offer engaging temporary contractor opportunities like this, to those who are looking for flexibility in their career while looking to gain new skills and experiences providing services to an inclusive global medicines company. Click here to learn more about Magnit www.magnitglobal.com
Ready to work with/through Magnit at Novartis? Please read on...
Quality Assurance( QA) Operations Associate
About this role:
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.
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.
Experience:
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
::Note : Worker has to be flexible with the shift mentioned above as they will be working 36-42 hours and personnel is required to wear PPE such as lab coat, hairnet, beardnet, coveralls, hood, booties. :::
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
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.
Salary : $25 - $28