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QA Validation Specialist - Onsite role

  • CGMP
  • FDA
  • GMP
  • Inspections
  • Laboratory
  • Operations
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... 
QA Validation Specialist - Onsite role

Duties:
§ Execute and/or approve deliverables for the Site Validation Plan enabling overall strategic implementation of remediation and qualification activities within the site’s commitments.
§ Work in close collaboration with site-based SMEs to ensure the implementation of robust, high-quality deliverables, with clear alignment between inspection SMEs and site leadership.
§ Review and approve actions related to facility, computerized systems, laboratory or products. Ensure proper assessment with respect to Qualification and Validation is conducted. Performs QA oversight for Validation and Qualifications activities for Manufacturing, QC and other GMP support areas.
§ Review and approval of deviations / non-conformances and lead the strategic discussion for investigations with respect to operations or validation related matters.
§ Support the site’s Inspection Readiness program for regulatory inspections, Novartis baseline audits /audits.
§ Actively drive high quality deliverables at the site by promoting a high standard of Quality Culture. Helps build and drive a culture of compliance throughout the organization.
§ Inspire change management initiatives and embed collaboration forums across the sites and as required with stakeholders. Control project scope to limit schedule changes and to capture changes of scope that may arise.

Background:
● B.S. degree in Science, Engineering or related field with 5 years’ relevant experience or MSc with 3 years of relevant experience.
● 5 years of experience in Pharmaceutical Manufacturing preferred, at least 3 years combined of relevant experience in quality-based roles including experience in GMP and/or laboratory operations required.
● Proven track record and practical experience in establishing and maintaining quality systems, in facility changes and validation as well as successfully managing authority inspections from major HA’s.
● In-depth knowledge of cGMP's, especially FDA regulations 21 CFR Parts 11 with preferred understanding of regulations for computerized systems
● Strong understanding and operating awareness of working in a pharmaceutical company. Experience in regulatory agency and partner/collaborator inspections.
● Good understanding of local/National Health Authorities regulations and Novartis standards
● Demonstrated ability to problem solve and mediate complex issues. Project management capabilities preferred.
● Strong communication, leadership and team working skills
● Effective in prioritizing, shows the appropriate sense of urgency around prioritized tasks. Flexibility and ability to prioritize and manage multiple tasks simultaneously
● Creative thinker in ways in which we can ensure better compliance and systems (A risk-based approach to Quality and Compliance)
● Demonstrated excellence in written and verbal communication. Ability to effectively communicate at all levels in the organization – oral and written
● Demonstrated ability to work cross-functionally
● Highly motivated, driven and have a passion to be part of a fast-paced team

Location: 100% onsite role at Millburn, NJ location
Pay Rate: $42 - $54/hour
Contract: 10 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 : 5+ Years
  • Travel Required : No travel required
  • Shift timings: Onsite in Millburn, NJ
Job Location
Millburn, New Jersey
Pay
USD 42.00 - USD 54.00 Per Hour
CONTRACT DURATION
10 month(s)
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