Quality Analyst III, Stability
Location:
, New Jersey
Posted:
January 23, 2017
Reference:
4895161227/1-en-us

Johnson & Johnson Consumer Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Analyst III, Stability in Fort Washington, PA or Skillman, NJ.

 

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. 

 

The Quality Analyst III, Stability will:

 
  • Oversee the External Manufacturing (EM) stability program (within the Consumer Source Quality organization).
  • Provide Quality Assurance expertise in the management of marketed product stability (MPS) studies at EM and Contract Laboratory sites to ensure activities comply with regulatory and J&J requirements. 
  • Act as a Subject Matter Expert (SME) for MPS.
  • Support external stability testing sites by driving compliance and quality improvement initiatives.
  • Manage and guide Out of Specification/Out of Trend (OOS/OOT) and non-conformance investigations (in partnership with Quality Engineers/Account Managers as applicable) to ensure that J&J requirements are met.
  • Review externally generated stability data/certificates of analysis (COAs), protocols, and reports.
  • Interface with J&J business partners, and participate on cross-functional teams representing the EM stability group.


Qualifications
  • A minimum of a Bachelor’s Degree in Chemistry, Biology, or related discipline is required.
  • A minimum of 5 years of experience working in the pharmaceutical or similarly regulated industry is required.
  • A minimum of 2 years of experience in a Quality Assurance, Regulatory Affairs, and/or Stability position is required.
  • Familiarity with ICH guidelines, SUPAC, and other regulatory body of knowledge related to stability programs is required.
  • Experience with statistical software packages (e.g., Minitab, SAS, Statistica, JMP) is preferred.
  • Understanding of OOS and OOT investigations is required.
  • Strong technical writing skills are required.
  • Experience partnering with manufacturers, testing laboratories, R&D groups, and technical operations is preferred.
  • Experience working with solid and liquid dose products is preferred.
  • Proficiency in MS Word, Excel, and Power Point applications is required.
  • This position can be based in Fort Washington, PA or Skillman, NJ and may require up to 10% domestic/international travel.


Primary Location
United States-New Jersey-Skillman
Other Locations
North America-United States-Pennsylvania-Fort Washington
Organization
J & J Consumer Inc. (6101)
Job Function
Quality (Generalist)

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.

Know someone who would be interested in this job? Share it with your network.