Stability/Retain Supervisor
Location:
Lancaster , Pennsylvania
Posted:
March 21, 2017
Reference:
2980170222-en-us

Johnson & Johnson Consumer Inc, a member of Johnson & Johnson's Family of Companies, is recruiting for a Stability/Retain Supervisor 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. 
 
 
  • Coordinate and supervise the activities of the Marketed Product Stability Program (MPS). Performs review of the stability protocols, study reports, stability annual reports, and statistical analysis of stability results so as to provide a high degree of assurance that all stability data is handle, managed, and approved in a technically component, compliant and efficient manner. Oversees the pull, testing and approval of the stability samples to ensure target dates are met. Performs stability related investigations. This position requires through knowledge of stability requirements, the ability to interact with other departments, and excellent written and oral communication skills. This position interacts with various internal departments and external divisions on a routine basis to coordinate stability efforts.
 
  • Coordinate and supervise the activities of the Retain Program. Ensures retain samples are collected, stored and maintained in accordance with Johnson & Johnson procedures and regulatory agencies. Coordinates and executes all required tasks to maintain the Sample Retain Program for the Analytical QC laboratory.  Responsible for sample management of all retain samples (ex. Finished products, raw materials, and packaging components). Supports Complaints, Annual visual Inspections and Annual Product Reviews.
 
  • Development and performance management of direct reports including: training, coaching and mentoring, goal setting, performance evaluation and feedback and, in association with the QC Analytical Laboratory Manager.
  • Ensures all work is performed and documented according to approved standard operating procedures and test methods, in general compliance with current Good Manufacturing Practices (cGMP) and in a timely manner consistent with agreed upon timelines and schedules
  • Assist the QC Analytical Laboratory Manager in the collection and use of metrics to monitor the quality, timeliness, efficiency and effectiveness of activities in the laboratory and lead initiatives to drive improvement in these areas
  • Oversee preparation of the Annual Stability Plan and review and/or approve Stability Reports.
  • Review and approval of Stability Protocols
  • Attend change control meetings and approving stability-related change controls
  • Oversee stability sample collection including monitoring production plans.
  • Oversee transfer of stability samples to external stability contract laboratories.
  • Review out of trend stability results and initiating nonconformance investigations in compliance with effective standard operating procedures.
  • Provide deliverables for stability change controls.
  • Oversee the Sample Retain Program.
  • Supports Complaints with requests for retain sample, as needed.
  • Oversees Annual Visual Inspections.
  • Supports Annual Product Reviews.

Qualifications
  • A minimum of a Bachelor’s degree is required.  Chemistry or a closely related physical or lifescience is preferred.
  • A minimum of four years of experience working in a pharmaceutical or similar regulated industry is required
  • Prior experience in a Supervisory role is preferred. 
  • Knowledge and understanding of cGMP and other regulatory guidance relevant to pharmaceutical stability, retains, annual product reviews and stability testing of pharmaceutical products is required.
  • Proficient computer skills (Excel, Power Point, MS Word, etc.). required
  • Experience with statistical software (ex. Minitab) is preferred
     
    This position is based in Lancaster, 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-Lancaster
Organization
J & J Consumer Inc. (6101)
Job Function
Quality Control

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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