Stability/Retain Program Specialist II
Location:
Lancaster , Pennsylvania
Posted:
January 12, 2017
Reference:
3403161208-en-us

Johnson & Johnson Consumer Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Stability/Retain Program Specialist II to be based in in Lancaster, 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. 

 
The Stability/Retain Program Specialist II will:
 
  • Coordinate and execute all required tasks to maintain the Sample Retention program for the Analytical Quality Control laboratory. 
  • Be responsible for sample management of all retain samples (ex. Finished products, raw materials, and packaging components).
  • Support Complaint and Annual Visual Inspections.
  • Support the Marketed Product Stability (MPS) Program by performing the following:
    • Create requests for samples, initiate studies in the MPS program, pull studies for testing and deliver to the laboratories, create stability protocols, create summary reports for annual review and the APR. 
    • Write the following documents:  SOPs and laboratory investigations related to retain and stability. 
  • Complete all requirements of the Retention and Stability programs according to standard operation procedures.
  • Ensure each sample in the Retention and Stability programs has the proper lifecycle.
  • Prepare sample for disposal and coordinate destruction with Quality Assurance.
  • Support the Marketed Product Stability (MPS) program Requirements.


Qualifications
  • A minimum of a Bachelor’s degree (or equivalent degree) is required.  
  • A degree focused in Chemistry, Biochemistry or closely related physical or biological science is preferred.
  • A minimum of 2 years of experience in a highly regulated industry is required.
  • Knowledge and understanding of cGMP and other regulatory guidance relevant to pharmaceutical stability, annual product reviews and stability testing of pharmaceutical products is highly preferred.
  • Past experience in a Quality or Regulatory role is preferred.
  • Strong analytical skills are required. 
  • Potential to be lifting approximately 50lbs
  • Position will be located in Lancaster, PA. 


Primary Location
United States-Pennsylvania-Lancaster
Organization
J & J Consumer Inc. (6101)
Job Function
Quality Assurance

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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