Novartis · 3 weeks ago
QC Investigations Expert (GMP Envirmt)
Morris Plains, NJ
Contract
Onsite
Entry, Mid Level
$32/hr - $35/hr
2+ years expNovartis is a global medicines company impacting the lives of millions. The QC Investigations Expert is responsible for leading manufacturing and QC investigation reports in support of cell therapy manufacturing operations, including conducting thorough investigations and ensuring timely completion of reports.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
Responsibilities
Conduct thorough investigations (OOS, OOT, Environmental Monitoring, deviations, etc.) utilizing root cause analysis tools
Lead investigations and cross functional investigation teams, and close reports in a timely manner
Interview personnel within QC and provide quality insight to complete laboratory investigation reports in 1QEM
Review/complete routine CAR-T manufacturing nonconformance/deviation investigations
Ensure all investigations are completed in a timely manner. Notify stakeholders of any delays in a timely manner
Provide technical support for manufacturing investigations / CAPAs / change controls as needed
Handle complex issues and solve problems with minimal guidance
Provide training to new investigations team members
Serve as author or technical reviewer of departmental procedures as appropriate
Work with functional teams to propose effective CAPAs, develop CAPA plans and assure CAPA effectiveness. Employ lean manufacturing / six sigma principles to continuously improve products, processes and systems
Build strong cross-functional and interdepartmental partnerships to ensure seamless execution of investigations and interface closely with different functional organizations, including Quality Assurance teams
Assess potential impact and risk to product or process associated changes may have upon change implementation and develop an appropriate mitigation strategy
May Initiate change control documentation
Identify functional area SMEs to perform impact assessments as part of the change management process
Support deviation investigation defense during audits and site inspections for QC compliance related inquiries
Qualification
Required
Bachelor's degree and 2-4 years of related pharmaceutical / biopharmaceutical work experience, or master's degree and 2-3 years of work experience
Minimum of 2 years of experience in a cGMP environment / commercial manufacturing
Extensive experience in a regulated GMP environment, preferably within QC operations in a cell therapy company
Knowledge of cGMP regulations and quality standards relevant to cell therapy manufacturing
Working experience of deviation investigations utilizing root cause analysis tools
Working experience in the CAPA process and ability to identify and verify effectiveness
Technical writing skills and ability to collaborate effectively in cross functional teams
Proven ability to accurately and completely understand, follow, interpret, apply Global Regulatory and cGMP requirements
Ability to support health authority inspections
Knowledge of data trending and tracking, including use of statistical analysis software a plus
Advanced knowledge and implementation of data integrity principles
Excellent communication, presentation, and interpersonal skills to effectively train diverse audiences
Strong analytical and problem-solving skills
Ability to function in a rapidly changing environment & handle multiple priorities
Ability to set priorities, manage timelines and effectively react/manage changing priorities
Ability to work with management (global and site) and support corporate and departmental goals
Ability to collaborate cross functionally to drive operational and quality excellence
Advanced organizational and time management skills
Ability to work independently and as part of a team to achieve quality objectives
Demonstrated critical reasoning, problem solving, troubleshooting, investigation, and decision-making skills
Communicate effectively with management regarding task completion, roadblocks, and needs
Ability to work collaboratively in a high-paced team environment, meet deadlines and prioritize work for multiple teams/programs
Benefits
Health
Dental
Vision
401k
Company
Novartis
Novartis is a pharmaceutical company that researches and develops medicines for serious diseases to improve and extend people's lives.
10001+ employees
H1B Sponsorship
Novartis has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (14)
2024 (27)
2023 (23)
2022 (27)
2021 (31)
2020 (25)
Funding
Current Stage
Public CompanyTotal Funding
$2.49BKey Investors
Bill & Melinda Gates Foundation
2024-06-19Post Ipo Debt· $2.49B
2018-02-14Grant· $6.5M
2000-05-19IPO
Leadership Team
Daniel Grant
Vice President & Global Program Head
John von Brachel
VP, Head of Content Lab
Recent News
2026-01-20
2026-01-20
2026-01-20
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