Johnson & Johnson Careers
Analyst IV, Complaint Vigilance
Requisition ID: 3765181004
Johnson & Johnson Consumer Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for an Analyst IV, Complaint Vigilance 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 IV, Complaint Vigilance evaluates adverse events and product quality complaints and conducts complaint investigation in accordance with Standard Operating Procedures using the Product Quality Management System. This may include, but is not limited to, complaint case review, trend analysis, return sample evaluation, malfunction coding, and complaint closure as applicable, investigation by manufacturing site and escalation, as appropriate.
In this role, you will have collaboration 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.
- Processes serious product complaints according to internal Standard Operating Procedures.
- Performs complaint case review, trend analysis, return sample evaluation, malfunction coding, as applicable, investigation by manufacturing site and escalation, as appropriate.
- Ensures all relevant data for complaints are obtained and well documented in accordance with closure timelines.
- Leads in the completion of periodic product complaint trend analysis, and Complaint Vigilance reports and presentations per established procedures.
- Prepares and issue meeting minutes, ensures action items are completed.
- Leads various projects and activities related to 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.
- Prepares reports as requested.
- Supports internal and external audits and participates as Subject Matter Expert as needed.
- Prepares and presents Complaint Vigilance data to QA Management and cross functional business partners.
- Develops and delivers training presentations for complaint vigilance process and systems.
- Creates and updates-controlled documents.
- 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 7 years of related experience, including Quality Assurance and/or Quality Control, including experience working in pharmaceutical, medical devices or other highly regulated industry is required.
- Experience working in an FDA regulated environment is required.
- Strong knowledge of GMP regulations, ICH and ISO guidelines is required.
- Experience supporting manufacturing, packaging, and development operations is required.
- Experience supporting many/all aspects of the complaint vigilance life cycle for pharmaceutical, medical device, and /or cosmetic/OTC products. Device and/or Pharmaceutical are strongly preferred.
- Experience with one or more technologies supporting complaint handling. PQMS or similar systems is preferred.
- Experience in the creation, update and management of complaint files from complaint identification through closure.
- 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 is preferred.
- Experience with systems and tools supporting analysis and reporting.
- This position will be based in Fort Washington, PA.
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.
United States-Pennsylvania-Fort Washington
J & J Consumer Inc. (6101)