Johnson & Johnson Consumer Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for an Analyst III, Complaint Vigilance (Triage) to be based 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 (Triage) 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.
- This may include, but is not limited to, review complaint case to verify customer verbatim, lot number, subject coding, trend analysis, malfunction coding, and complaint closure as applicable, and escalate, as needed. Ensures all relevant data for complaints are obtained.
- Evaluates and assigns serious complaints to sites. Collaborates 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.
- Have the ability to assist with various projects within the department, communicate effectively with management. This role will analyze data and other trends.
- 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. Supports internal and external audits and inspections for McNeil products.
- 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 Fort Washington, PA and may require up to 10% travel depending on business needs.
United States-Pennsylvania-Fort WashingtonOrganization
J & J Consumer Inc. (6101)Job Function
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.