Johnson & Johnson Careers
Analyst IV, Global Complaint Vigilance Systems and Trending
Requisition ID: 1183180904
Johnson & Johnson Consumer Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for an Analyst IV, Global Complaint Vigilance Systems and Trending to be based in Skillman, NJ or 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, Global Complaint Vigilance Systems and Trending leads complex analytics activities and develops solutions for global business partners. The Analyst IV performs analysis of data to support global metrics, trend analysis and risk management planning.
In this role, you will have collaboration with business quality team members in other regions to develop procedures and technical rationale documents in support of projects and procedural changes.
- Complete periodic product complaint trend analysis, Complaint Vigilance reports and presentations per established procedures.
- Analyze data and perform periodic complaint trend analysis.
- Collaborate 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.
- Lead various projects within the department, and communicate effectively with all levels of management.
- Lead and develop training presentations for complaint vigilance process and systems and creation and updates of controlled documents.
- Will prepare and present Complaint Vigilance data to QA Management and cross functional business partners.
- Process serious product complaints according to internal Standard Operating Procedures, as appropriate.
- Perform complaint case review, trend analysis, return sample evaluation, malfunction coding, as applicable, investigation by manufacturing site and escalation, as appropriate.
- Ensure all relevant data for complaints are obtained and well documented in accordance with closure timelines.
- Prepare and issue meeting minutes, ensure action items are completed.
- Monitor Complaint Records in PQMS to ensure standard process is being followed and complaints are closed as required, and will prepare reports as requested.
- Support internal and external audits and may participate as Subject Matter Expert as needed.
- 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 6 years of related experience, including Quality Assurance and/or Quality Control, in a highly regulated environment is required.
- Experience supporting manufacturing, packaging, and development operations is a must.
- 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, ICH and ISO guidelines is required.
- Ability to handle issues using deductive reasoning, critical analysis skills and systematic approaches is required.
- 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
- Knowledge of basic manufacturing processes and associated GMP compliance requirements are strongly preferred.
- Ideal candidate must be able to be onsite in Skillman, NJ a minimum of 3 days.
- This position will be based out of Skillman, NJ or Fort Washington, PA and may require up to 10% travel depending on business needs.
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-New Jersey-Skillman
United States-Pennsylvania-Fort Washington
J & J Consumer Inc. (6101)