Quality Assurance Specialist New Products

Quality Assurance Engineer; New Products

The Quality Assurance Engineer shall be responsible for providing overall Quality Assurance support of New Product Introductions, products at external (contract) manufacturing sites engaged in the production of Cosmetics and Personal Care Consumer Products.

Under minimal supervision, the QE shall support activities at established external manufacturing sites via the following:

• 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.

Requirements

Preferred experience:

• 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 FDO regulations

Benefits

A comprehensive benefits package which includes medical, dental, vision, disability and life insurance, 401k and a generous PTO Policy.