Analyst III, Complaint Vigilance (1 of 2)
Location:
, New Jersey
Posted:
January 12, 2017
Reference:
3123161206-en-us

Johnson & Johnson Consumer Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for an Analyst III, Complaint Vigilance to be based in 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 Analyst III, Complaint Vigilance will:
 
  • Evaluate adverse events and product quality complaints and processes cases in accordance with Standard Operating Procedures using the Product Quality Management System.
    • This may include, but is not limited to, reviewing complaint case to verify customer verbatim, lot number, subject coding, trend analysis, malfunction coding, and complaint closure as applicable, and escalation, as needed.
  • Collaborate with External Manufacturing Sites, Internal Manufacturing Sites, External Manufacturing QA, Business Quality, Medical Safety, R&D and other business partners to ensure the integrity, consistency, compliance, and alignment of the end-to-end complaint vigilance process.
  • Assist with developing training presentations for complaint vigilance process and systems and creation and updates of controlled documents.
  • Assist with various projects within the department, and communicate effectively with all levels of management.
  • Analyze data and perform periodic complaint trend analysis.
  • Will prepare and present Complaint Vigilance data to QA Management and cross functional business partners.
  • Process serious product complaints according to internal Standard Operating Procedures.
  • Perform complaint case review, trend analysis, return sample evaluation, malfunction coding, as applicable, investigation by manufacturing site and escalation, as appropriate.
  • Ensure all relevant data for complaints are obtained and well documented in accordance with closure timelines.
  • Complete periodic product complaint trend analysis, Complaint Vigilance reports and presentations per established procedures.
  • Prepare and issue meeting minutes, ensure action items are completed.
  • Monitor Complaint Records in PQMS to ensure standard process is being followed and complaints are closed as required, and will prepare reports as requested.
  • Support internal and external audits and may participate as Subject Matter Expert as needed.


Qualifications
  • A minimum of a Bachelor’s degree (or equivalent degree) is required.
  • A degree focused in Science, Engineering or related field is preferred.
  •  A minimum of 5 years of related experience, including Quality Assurance and/or Quality Control, in a highly regulated environment is required.
  • Experience working in an FDA regulated environment is required.  
  • Experience supporting many/all aspects of the complaint vigilance life cycle for pharmaceutical, medical device, and /or cosmetic/OTC products is required.
  • Complaints Vigilance experience focused in Medical Device and/or Pharmaceutical is strongly preferred.
  • Strong knowledge of GMP regulations is required.
  • Experience with PQMS or similar Complaint Management system is preferred.
  • Experience supporting manufacturing, packaging, and development operations is preferred.
  • This position will be based out of Skillman, NJ and may require up to 10% travel depending on business needs. 



Primary Location
United States-New Jersey-Skillman
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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