Analyst III, Complaint Vigilance in Skillman, New Jersey | DiversityInc Careers
 
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Analyst III, Complaint Vigilance


Johnson & Johnson Consumer Inc, a member of Johnson & Johnson's Family of Companies, is recruiting for an Analyst III, Complaint Vigilance to be located 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 evaluates adverse events and product quality complaints and processes cases in accordance with Standard Operating Procedures using the Product Quality Management System.


In this role, you may be involved with the review of complaint case to verify customer verbatim, lot number, subject coding, trend analysis, assignment of complaint to manufacturing site, review of manufacturing investigation, complaint summary and complaint closure and escalation. You will 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. You will assist with developing training presentations for complaint vigilance process and systems and creation and updates of controlled documents. 

Responsibilities include but are not limited to:

  • Processes product quality complaints and adverse events according to internal Standard Operating Procedures. 
  • Performs review of complaint case to verify customer verbatim, lot number, subject coding, trend analysis, assignment of complaint to manufacturing site, review of manufacturing investigation and complaint closure as applicable, and escalate, as needed, in a timely manner. 
  • Ensures all relevant data for complaints are obtained.
  • Collaborates with Call Centers, Medical Safety, Marketing, Internal affiliates, External sites, and other business partners to ensure appropriate complaint handling. 
  • Evaluates and assigns complaints requiring investigation to sites.
  • Collaborates with internal and external sites to become familiar with product/manufacturing sites.
  • Reviews and summarizes completed complaint investigations. 
  • Completes periodic product complaint trend analysis, Complaint Vigilance reports and presentations per established procedures. 
  • Assists with various projects and activities related to Central Complaint Vigilance process and system implementations and improvements.
  • Monitors 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. Supports ADPR, Monthly Signal Analysis and CVRBs.
  • Supports internal and external audits and inspections as a Subject Matter Expert as needed.


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 manufacturing, packaging, and development operations is preferred.
  • 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.
  • 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-New Jersey-Skillman
Organization
J & J Consumer Inc. (6101)
Job Function
Quality Assurance
Requisition ID
0680180826