Johnson & Johnson Careers

Analyst III, Complaint Vigilance

Fort Washington, Pennsylvania
Quality Assurance


Job Description

Requisition ID: 1374180906

Johnson & Johnson Consumer Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for an Analyst III, Complaint Vigilance, 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 Analyst III, Complaint Vigilance will:

  • Triage and evaluate non-serious and serious product quality complaints and processes product quality complaints in accordance with Standard Operating Procedures using the Product Quality Management System. 
  • Review complaint case to verify customer verbatim, lot number, subject coding, trend analysis, malfunction coding, and complaint closure as applicable, and escalate, as needed. 
  • Evaluate and assign serious complaints to sites. 
  • Collaborate with internal and external sites to become familiar with product/manufacturing sites. 
  • Collaborate with Call Centers, Medical Safety, Marketing, Internal affiliates, External sites, 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, and deliver training to colleagues and partners.
  • Lead various projects within the department, communicate effectively with all levels of management (internally & externally).
  • Analyze data and other trends, and present/report to senior management. 
  • Monitor Complaint Records in PQMS to ensure standard process is being followed and complaints are closed as required.
  • Compile product and lot-specific complaint trending data and complaint closure metrics as requested.
  • Provide review and feedback of product and lot-specific trending data prepared by Analyst II and Analyst III levels. 
  • Support internal and external audits/inspections and may participate as subject matter expert.


Qualifications
  • A minimum of a Bachelor’s Degree is required.  A focus in Science, Engineering, or related discipline is preferred.
  • A minimum of 5 years of related experience including Quality Assurance and/or Quality Control is required.
  • Experience working in pharmaceutical, medical devices or other related or highly regulated industry is required.
  • Demonstrated knowledge and expertise in quality processes and regulatory requirements is required.
  • Experience working in an FDA regulated environment is required.
  • Experience supporting many/all aspects of the complaint vigilance life cycle for pharmaceutical, device, and /or cosmetic products is preferred.
  • Experience with one or more technologies supporting complaint handling preferred.
  • PQMS or similar system preferred.
  • Experience in the creation, update, and management of complaint files from complaint identification through closure is preferred.
  • Expertise with root cause analysis techniques including but not limited to: Brainstorming, data analysis and collection tools, 5 Whys, Fishbone (Cause and Effect), FMEA, and DMAIC preferred
  • Experience with tools and techniques supporting qualitative risk analysis including but not limited to: Probability and impact assessment (likelihood of recurrence and potential effect), probability and impact matrix (risk ratings, rating rules), and risk categorization (by root causes, other qualifiers) is preferred
  • Experience with systems and tools supporting analysis and reporting preferred.
  • Experience in a manufacturing-related environment is preferred.
  • This position may require up to 10% domestic travel as business demands.

Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.

 
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

Primary Location
United States-Pennsylvania-Fort Washington
Organization
J & J Consumer Inc. (6101)
Job Function
Quality Assurance
Requisition ID
1374180906