200+ applicants
Endeavor Consulting Group, LLC ยท 5 days ago
Quality Assurance Specialist New Products
Princeton, NJ
Full-time
Onsite
Mid Level
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Insider Connection @Endeavor Consulting Group, LLC
Responsibilities
Manage the QA of NPI; First Article of Inspection, batch Release, label review
Reports, tracks, and follows up on deficiencies noted at external manufacturing sites, including assessments, audits, investigations, and overall site performance.
Lead the remediation of Quality process issues with the external manufacturing site
Proactive participation on new product development teams, including coordination with Technical Transfer team, to ensure that all projects meet specified QA launch requirements and timelines.
Guidance and review in the development of APR and change control documentation for new product launches and commercialized products, respectively.
Review of specifications and validation documentation related to base business projects and new product introductions.
Guidance in the implementation of compliance and quality improvement initiatives at external manufacturing sites, during product development, scale-up, validation, and launch.
Routine interaction with internal business partners and external manufacturing sites, in support of commercialization and documentation readiness.
Compliance with processes and controls, as well as with cGMP and FDA guidelines, to ensure that product quality and performance conform to established standards.
Troubleshoots quality problems, provides thorough and practical assistance in the resolution of process / product non-conformance events, and assists in the development of corrective actions to prevent reoccurrence, leveraging Quality Systems.
Drives resolution of consumer complaints through quality investigations and root cause analysis.
Develops processes and procedures and delivers training in quality-related subjects to the QA division partner functions, business partners, licensees, and external manufacturing sites.
Administers domestic consumer brand product release program and effectively communicates significant problems or delays to supply chain personnel.
Additional responsibilities may include: Follow-up on internal and external compliance audit management action plans (MAPs), Review of process / product-related documentation, Generation and issuance of Quality Responsibility Agreements, Other duties as assigned.
Qualification
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Required
QA Experience in the Personal Care, Cosmetics, Beauty Consumer Products industry
Pharmaceutical or OTC experience also a plus
Understanding of Regulatory requirements
Experience in a GMP facility a must; deep knowledge of FDA regulations
Benefits
Medical Insurance
Dental Insurance
Vision Insurance
Disability Insurance
Life Insurance
401k
Generous PTO Policy
Company
Endeavor Consulting Group, LLC
Endeavor Consulting Group is an IT company offering project management services.
Founded in 2006
51-200 employees
H1B Sponsorship
Endeavor Consulting Group, LLC 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
2022 (7)
Funding
Current Stage
Growth StageLeadership Team
B
Benoit David
Managing Partner & CEO
Recent News
2024-06-03
Company data provided by crunchbase
