QUALITY & COMPLIANCE SPECIALIST

Kelly Outsourcing Consulting Group Kelly OCG, a managed solution provider and business unit of Kelly Services, Inc., is currently seeking a Quality & Compliance Specialist for a long-term engagement at one of our Global consumer products clients in Skillman, NJ.

SUMMARY

The Quality and Compliance Specialist will serve as the end-to-end quality support of Skin Health products for product quality and compliance within Franchise Quality, Product Lifecycle Management (PLM).

Responsibilities:

• Global Change Control (GCC) to ensure that all work has been conducted according to the Company Development Plan, established procedures, and regulatory requirements
• Partners with Product Development, Technical Transfer and Manufacturing functions to define the product and process Critical-to-Quality (CTQ) / Critical Process Parameters (CPPs).
• Responsible for the final coordination and flawless execution of new product activities between R&D, Franchise Quality, MAKE Quality, Operations and Supply Chain, including high quality documentation for Approval for Product Release (APR).
• Key Skill Sets Desired:
• Problem solver and proactive strategic thinker
• Ability to influence without authority, overcome challenges, and effectively negotiate with colleagues across levels and functions
• Ability to independently plan, organize, co-ordinate, run and complete assigned tasks
• Excellent communicator with outstanding interpersonal skills and tact

Qualifications

• A minimum degree of BS in Science/Engineering is required.
• Minimum of 3yrs of industry experience in these responsibilities.
• Experience in Healthcare or Pharma industry a plus.
• Understanding of Regulatory requirements in R&D development.
• Experience with Trackwise,Veeva, and MS Office required.
• Strong Communication and Interpersonal skills required.

• Global Change Control (GCC) to ensure that all work has been conducted according to the Company Development Plan, established procedures, and regulatory requirements
• Partners with Product Development, Technical Transfer and Manufacturing functions to define the product and process Critical-to-Quality (CTQ) / Critical Process Parameters (CPPs).
• Responsible for the final coordination and flawless execution of new product activities between R&D, Franchise Quality, MAKE Quality, Operations and Supply Chain, including high quality documentation for Approval for Product Release (APR).
• Key Skill Sets Desired:
• Problem solver and proactive strategic thinker
• Ability to influence without authority, overcome challenges, and effectively negotiate with colleagues across levels and functions
• Ability to independently plan, organize, co-ordinate, run and complete assigned tasks
• Excellent communicator with outstanding interpersonal skills and tac