Specification Lead
Location:
Fort Washington , Pennsylvania
Posted:
March 29, 2017
Reference:
8223170215-en-us

Johnson & Johnson Consumer Inc, a member of Johnson & Johnson's Family of Companies, is recruiting for a Specification Lead, in Fort Washington, PA.
 
Johnson & Johnson Family of Companies touches more than a billion people’s lives each day through our health care products and services, our corporate giving, and the volunteer efforts of our employees. The Johnson & Johnson Group of Consumer Companies develop and market beloved brands that address the needs of consumers and health care professionals worldwide. Our portfolio ranges across several distinct business units:  Baby Care, Oral Care, Compromised Skin Care, Beauty, Feminine Care, and Over-The-Counter (OTC) products. 
 
Principle Responsibilities:
 
  • Chairperson of the Product Specification Justification (PSJ) Committee.
  • Reviews and approves PSJ ensuring compliance with USP, FDA, ICH, and internal guidelines.
  • Collaborator with R&D to ensure documents supporting PSJs are properly approved.
  • Approves and reviews Finished Product Test Methods and Specifications.
  • Approves and reviews Raw Material Specifications.
  • Works with R&D and Regulatory Affairs to provide compliance input on issues that may arise setting specifications.
  • Provides the collaboration “Specifications” for the Annual Product Report.
  • Maintains metrics.
  • Works with multidisciplinary groups in different projects as SME for specifications.
  • Maintains up to date knowledge of industry practices.

Qualifications
  • A minimum of a Bachelor’s Degree is required.  A focused degree in Chemistry, Biology or Life Science discipline preferred.  
  • 8+ years of experience working in the pharmaceutical or similar regulated industry is required. 
  • 4+ years of experience in a Quality Assurance and/or Regulatory Affairs position is required. 
  • Familiarity and understanding of ICH, FDA and other regulatory body guidance related specifications for FP and RM apps is required.
  • Experience setting specifications, partnering with manufacturing, QC laboratories, research and development is preferred. 
  • Experience working with solid dose, liquid, suspensions, and topicals is preferred. 
  • Experience interacting with Regulatory Authorities is preferred
 
This position is based in Fort Washington, PA.
 
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
 

Primary Location
United States-Pennsylvania-Fort Washington
Organization
J & J Consumer Inc. (6101)
Job Function
Quality (Generalist)
Requisition ID
8223170215

A little about us:
Johnson & Johnson cares for the world - bringing innovative ideas, products and services to advance the health and well-being of people.

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