Quality Assurance Validation Manager
Location:
Fort Washington , Pennsylvania
Posted:
April 02, 2017
Reference:
6031170112-en-us

Johnson & Johnson Consumer Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Assurance Validation Manager 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. 

 
The Quality Assurance Validation Manager will:
 
  • Provide quality management oversight to the QA validation group.
  • Provide support to site facilities, utilities, instruments and equipment qualification and process, packaging, computer systems, and cleaning validation.
  • Lead in the development, review and implementation of validation documents, quality and engineering procedures. 
  • Review and approve documentation for validation and qualification activities to support company, equipment, product and/or performance processes. 
  • Be the Quality lead in the development of the Master Validation Plans, Project Plans, and Test Plans.
  • Provide guidance and oversee the maintenance of the validated state including requalification/revalidation of equipment and processes. 
  • Initiate, review, and approve change controls/engineering change notices, investigations, discrepancies/deviations, and audit responses.
  • Be the QA Validation SME (Subject Matter Expert) to understand the critical aspect of product, component and labeling requirements.
  • Review and sign off on relevant documentation per the function (i.e. QA validation) as required by the quality process in the execution of the relevant work.


Qualifications
  • A minimum of a Bachelor’s degree (or equivalent degree) is required  
  • A degree focused in Science, Computer Science or Engineering is preferred
  • Lead/Supervisory or Management experience is required
  • A minimum of 8 years of related experience within a GMP environment is required
  • Strong knowledge of multiple validation disciplines is required
  • Ability to interpret and apply GMP requirements is required
  • Strong knowledge of Computer Systems Validation is highly preferred
  • Expert knowledge/understanding of drug manufacturing and packaging processes from sampling and inspection through warehouse distribution is preferred
  • Expert knowledge/understanding of the product development life cycle is required
  • Intermediate/Expert user in various computer systems: ERP, LIMS, MES and Microsoft Office (including Outlook, Word, Project, Excel, PowerPoint) is preferred 
  • Intermediate understanding of PLC programs is preferred
  • This position will be located in Fort Washington, PA and may require up to 5% travel


Primary Location
United States-Pennsylvania-Fort Washington
Organization
J & J Consumer Inc. (6101)
Job Function
Quality Systems
Requisition ID
6031170112

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.