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QA Associate (EG)

  • Batch Record Review
  • CGMPS
  • LIMS
  • QA
  • SAP
  • Trackwise
Description:

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... 
In planning for 2024, in the month(s) ahead, we anticipate hiring for this role:

QA Associate
 The Quality Operations Associate is responsible for first level, hands on, day-to-day cGMP facilitator role for all site related GMP activities. They interact directly with site staff, who are performing the daily operational functions in support of their effort to produce quality products. This role ensures that the quality strategy is implemented and that there is a continuous drive to improve product and process quality within the PU

Major Accountabilities (Describe the main results of the job to be achieved )
This position will be expected to work a 4 day/10 hr work shift. (Sunday through Wednesday or Wednesday through Saturday, some evenings may be required)
• Under the guidance of the Quality Operations Process Manager/Team Manager, provides oversight to operations on the shop floor, supporting operators and support staff as needed to identify and address product quality and compliance issues as they arise.
• Review and audit production batch records to ensure adherence to Novartis policies, SOPs, and cGMP requirements.
• Conduct routine shop floor tasks related to aseptic operations including but not limited to ViMOS, APV program observations, walkthrough program, QA area release, etc.
• Interface closely with PU to assist with batch record review, release and compliance issues.
• Under the guidance of the Quality Operations Process Manager/team manager, perform triaging of events, initiate deviation reports in the appropriate quality system and partner PU and other areas for issue resolution.
• Actively participate in process improvement initiatives aiming for Right First Time (RFT) on documentation and deviation reduction.
• Ensures adequate levels of documentation are adequate and compliant to existing procedures
• Review and approval of track and trend and minor deviation investigations and assist in CAPA plan establishment in accordance with applicable SOPs.
• Participates in activities associated with event resolution and CAPAs with a focus on organizing and attending cross-functional meetings
• Implements and ensures adherence of appropriate regulations and Novartis quality standards.
• Write, review and approve Standard Operating Procedures (SOPs), as needed
• Assist QA Experts, Process Manager, and Team Managementin providing documentation as needed for self-inspections and external audits.
• Assist in audit preparation for shop floor tours as needed
• Champion a Quality Culture and ensure a safe working environment.
• Complete job-related training as required
• Perform or support any other tasks necessary to maintain the product quality and site cGMP compliance, as needed.
• Demonstrates and role models the Novartis values and behaviors

 Education: 
BA degree in Biological Sciences or equivalent relevant career experience may be accepted.
 
 Experience:
 • A minimum of 2 years of experience in a Pharmaceuticals environment.
 • Knowledge and understanding of cGMPs, keeping up to date with current industry
 issues and changing regulations.
 
 Competency Profile
 Specific Professional Competencies: Indicate any other soft/technical/professional knowledge and skills requirements
• Excellent oral and written communication skills required.
• Demonstrate leadership ability and excellent interpersonal skills.
• Ability to work under direction of senior team members, independently, and as part of a team if necessary. Strives for simplicity and clarity.
• SAP, Trackwise, MES, LIMS knowledge preferred
• Experience in Deviation Management and batch disposition preferred\
 
Location: Morris Plains - 100% onsite 
 Pay Rate: $28 - $35/hour 
Contract: 6-12 months 
Health, dental, vision, 401k

Why Novartis? 
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives. 
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. 
We believe we can reinvent what's possible when we collaborate with courage to ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! 
Imagine the impact you could make here at Novartis! 
  
Commitment to Diversity & Inclusion: 
Novartis is committed to building an outstanding, inclusive work environment with diverse teams representative of the patients and communities we serve. 
To do our best work we need different viewpoints, which is why here at Magnit, we celebrate diversity and embrace inclusion. As an equal opportunity employer, Magnit is dedicated to building a team that represents a variety of backgrounds, perspectives, and skills. We strive to ensure that we maintain a positive and enriching work environment for all. 
  
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 or 1.862.778.5441. 


Commitment to Diversity and Inclusion / EEO

QUALIFICATION/ LICENSURE :
  • Work Authorization : Green Card, US Citizen, Other valid work visa
  • Preferred years of experience : 2+ Years
  • Travel Required : No travel required
  • Shift timings: Morris Plains - 100% onsite
Job Location
Morris Plains, New Jersey
Pay
USD 28.00 - USD 35.00 Per Hour
CONTRACT DURATION
6 month(s)
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