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QA Officer Operations

CGMP
GCP
ICH
Clinical Trials
Medical Devices
Laboratory
FDA
Drug Development
Life Sciences
ADME
CLIA
Laboratory
GCP
Clinical Trials
CGMP
QA
Quality Assurance
ASQ
CGMP
CQA
CQE
Description:

~~~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...
Precision Medicine QA Associate

Primary Responsibilities
- Provide operational and quality support across strategic initiatives and workstreams within
Precision Medicine program team and PM QA.
- Collaborate with the PM QA lead to evaluate current QA processes, identify gaps, and co-drive
improvement efforts to strengthen compliance, efficiency, and documentation standards.
- Facilitate cross-functional project management meetings, manage action tracking, and oversee
project timelines and deliverables.
- Develop and maintain high-quality documentation, reports, and presentations for internal and
external stakeholders.
- Support risk monitoring, audit readiness, and CAPA activities, ensuring alignment with global
regulatory and GxP requirements.
- Contribute to broader CQA team initiatives and workstreams as needed.

Required Qualifications
- Bachelor’s degree in Life Sciences, Pharmacy, or a related discipline.
- 3-5 years of experience in Quality Assurance or Engineering within IVD, Medical Devices, or
Diagnostics, including embedded software and manufacturing.
- Demonstrated experience in drug development, clinical trials, and diagnostic laboratory settings.
- Strong working knowledge of:
- - 21 CFR 820 and 812
- - ISO 13485, 14971, 15189
- - CLIA, cGMP, GCP
- - EU IVDR (In Vitro Diagnostic Regulation)
- Proficiency in audits, compliance documentation, and stakeholder engagement.
- ASQ CQE/CQA certification is advantageous.
Preferred Qualifications
- Experience in GxP-regulated environments and familiarity with global regulatory frameworks
(FDA, EMA, ICH).
- Proven ability to work effectively in matrixed and global team structures.
- Clinical QA experience is an added advantage

Location: East Hanover, NJ (Hybrid)  (Remote Considered for East Coast Time Zone)
Pay Rate:$35.50/Hour - 43.11/Hour (W2 Only - based on Education and Experience)
Shift: 7:30 AM - 4:30 PM ET
Contract: 6-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.
 

QUALIFICATION/ LICENSURE :
  • Work Authorization : Green Card, US Citizen, OPT/CPT
  • Preferred years of experience : No preferred years of experience required
  • Travel Required : No travel required
  • Shift timings: Remote Considered (East Coast Time Zone only)
Job Location East Hanover, New Jersey (Hybrid)
Pay USD 35.50 - USD 43.11 Per Hour
Contract Duration 6 month(s)