Johnson & Johnson Careers
Analyst III, Complaint Vigilance
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.
- 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.
United States-Pennsylvania-Fort Washington
J & J Consumer Inc. (6101)