COMPLAINT VIGILANCE INVESTIGATIONS ANALYST III

Johnson & Johnson Consumer Inc., a member of the Johnson & Johnson Family of Companies, is recruiting for a Compliant Vigilance Investigations Analyst III located at Guelph Ontario! Johnson & Johnson Consumer Inc., is one of the world's largest consumer health and personal care products company. Our consumer companies produce many of the world's most trusted brands, among them JOHNSON'S® Baby, BAND-AID®, NEUTROGENA®, TYLENOL®, MOTRIN®, and LISTERINE®. Each one of our consumer businesses embraces innovative science to create products that anticipate consumer needs and create experiences that help them live healthy, vibrant lives. Are you interested in joining a diverse team that is helping to improve customer care and product quality? Apply today! The Analyst is responsible for triaging, evaluating, and investigating product quality complaints for J&J Consumer products in accordance with SOPs using the Product Quality Management System. We partner on local, regional and global levels with Global Consumer Care Center (GCCC), Medical Safety, Quality (External and Internal sites), Post Market Surveillance (PMS), and other business partners to ensure the integrity, consistency, compliance, and alignment of the end-to-end complaint vigilance process. This role reports to the Supervisor, Complaint Vigilance Investigations. Key Responsibilities: Review complaint cases to verify customer verbatim, lot number, subject coding, trend analysis, malfunction coding, reportability assessments, complaint summary, complaint closure, critical issues, analyze data and other trends. Prepare for regulatory submissions, assignment of complaint to manufacturing site, and review of manufacturing site investigation (collaborate with sites to become familiar with product/manufacturing sites). Assist with field sample management process for products returned from Consumer. Assist with developing training presentations for complaint vigilance process and systems and create/update controlled documents. Prepare and present Complaint Vigilance data to QA Management, PMS partners and business partners. Participate directly or indirectly on complaint vigilance initiatives and project teams to develop, consolidate, and/or improve complaint vigilance and related processes. Collaborate with Make Quality, GCCC, Medical Safety, Regional Quality, Regional R&D, PMS, External and Internal Sites, and other business partners to ensure appropriate complaint handling. Support ADPR, Monthly Signal Analysis, CVRBs, and PMS activities. Support internal and external audits and inspections as a subject matter authority. Qualifications Education: Bachelor’s Degree focused in Science, Engineering, or related field; or equivalent experience including Quality Assurance and/or Quality Control working in pharmaceutical, medical devices or other highly regulated industry Skills & Experience: Required: Minimum 5 years of relevant work experience Quality Assurance and/or Quality Control experience Experience working in pharmaceutical, medical devices, a health authority regulated environment or other related or highly regulated industry Proven knowledge and expertise in quality processes and regulatory requirements Preferred: Experience supporting Manufacturing, Packaging, and/or Development Operations Experience supporting many/all aspects of the complaint vigilance life cycle for pharmaceutical, device, and /or cosmetic products Medical device regulations and vigilance reporting experience Complaint handling software applications experience Experience with systems and tools supporting analysis and reporting including Tableau and/or Tableau dashboard development Experience working with Artificial Intelligence in Complaint processes Experience creating, updating, and managing complaint files from complaint identification through closure Expertise with root cause analysis techniques such as Brainstorming, data analysis and collection tools, 5 Whys, Fishbone (Cause and Effect), FMEA, and/or DMAIC Proficient 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 grid (risk ratings, rating rules), and/or risk categorization (by root causes, other qualifiers) Other: English fluency (read/speak/write) required May require up to 20% travel, domestic and international At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of full COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com. Diversity and inclusion are central elements of the shared culture across the Johnson & Johnson Family of Companies. Attracting, developing and retaining a workforce that reflects the diversity of our customers and communities is essential to our success. We are committed to providing a respectful, inclusive and accessible work environment where all employees have the opportunity to achieve their potential. Primary Location Canada-Ontario-Guelph-890 Woodlawn Road West Organization Johnson & Johnson Inc. (7695) Job Function Quality Requisition ID 2206047834W