26 applicants
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Innova Solutions ยท 2 days ago
Associate Scientist
Summit, NJ
Contract
Onsite
Entry Level
$45/hr - $49/hr
1+ years exp
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Hiring Manager
Mohit Vyas
Insider Connection @Innova Solutions
Responsibilities
Conduct thorough investigations utilizing root cause analysis tools
Lead cross-functional investigation teams and close reports in a timely manner
Perform GEMBA walks with stakeholders to understand process steps and evaluate Root Cause Analysis
Propose effective CAPAs and develop CAPA plans
Assess potential impact and risk of changes, and develop mitigation strategies
Initiate change control documentation
Ensure timely completion of investigations and notify stakeholders of any delays
Provide technical support for manufacturing investigations, CAPAs, and change controls
Support deviation investigation defense during audits and site inspections
Handle complex issues and solve problems with minimal guidance
Serve as author or technical reviewer of departmental procedures
Employ lean manufacturing/six sigma principles to improve products, processes, and systems
Support the 'patients first' mission and foster a 'Right First Time' mindset
Qualification
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Required
Bachelor's Degree in science or engineering, preferably in Biochemistry, life sciences or related engineering discipline (advanced degree preferred)
Minimum 1 year of relevant work experience, preferably in a health authority regulated environment
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
Hands on experience preferred with CAR-T or biopharmaceutical manufacturing and Quality Control
Preferred
Previous experience working in a biopharmaceutical manufacturing facility is preferred (CAR T a plus)
Knowledge of data trending and tracking, including use of statistical analysis software a plus
Ability to utilize electronic Quality systems such as eQRMs (Enterprise Quality and Regulatory Management system) or Infinity
Benefits
Medical & pharmacy coverage
Dental/vision insurance
401(k)
Health saving account (HSA) and Flexible spending account (FSA)
Life Insurance
Pet Insurance
Short term and Long term Disability
Accident & Critical illness coverage
Pre-paid legal & ID theft protection
Sick time, and other types of paid leaves (as required by law)
Employee Assistance Program (EAP)
Company
Innova Solutions
Innova Solutions is an IT company that specializes in data analytics, cloud computing, cyber security, and machine learning.
10,001+ employees
H1B Sponsorship
Innova Solutions 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
Trends of Total Sponsorships
2023 (248)
2022 (74)
2021 (32)
2020 (79)
Funding
Current Stage
Late StageLeadership Team
Raj Sardana
Founder, Chairman and CEO
Company data provided by crunchbase
