Complaint Analyst in Raritan, NJ

• Exhibits a strong quality assurance mindset. Ability to quickly identify deficiencies within investigation and other reports received. 
• Exhibit strong ability to collaborate and influence Business Partners (Internal Manufacturing sites, External Business Partners, regional ESIQ organizations, Brand Protection, Central Complaint Vigilance, etc) to ensure appropriate complaint handling and improve complaint management processes. 
• Works independently, challenges the status quo, identifies gaps and drives process improvements using Process Excellence tools. Participates and/or leads special projects 

COMPLAINT MANAGEMENT: 
• Process and analyze product complaints according to Policies and Standard Operating Procedures. 
• Communication of potential serious PQC’s in a timely manner, as appropriate. 
• Review complaint investigations for accuracy and completeness. Ensure standard process is followed, and data is consistent and of high quality to assist with correct decision making. 
• Compile product and site-specific complaint trending data and complaint closure metrics as requested 
• Support internal and external audits and inspections. 
• Participate within and/or facilitate special projects. 

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DOCUMENTATION: 
• Review product quality complaint and investigation documentation to ensure quality and accuracy of information. 
• Compile product and site-specific complaint trending data and complaint closure metrics as requested. Support internal and external audits and inspections. 

RELATED EXPERIENCE : 
• related experience including Quality Assurance and/or Quality Control, including experience working in pharmaceutical and/or Medical Device or other related or highly regulated industry. 
• Relevant knowledge on root cause investigations (production, lab environment) 
• Strong communication, organizational and project management skills. 

LIST JOB SPECIFIC COMPETENCIES/SKILLS REQUIRED: 
1. Strong interdependent partnering skills, interpersonal communication, influencing skills. 
2. Can work independently in a global environment/virtual team 
3. Global mindset 
4. Ability to interpret data and provide feedback to management 
5. Demonstrated knowledge and expertise of manufacturing processes, complaint vigilance global regulatory requirements, including 21CFR parts 210 and 211, ICH Q10 and CFR 820.198. 
6. Ability to allocate and balance competing priorities 
7. Competency in understanding system functionality (i.e. Product Quality Complaint Management System) in relation to process requirements. 
8. Fluent in English. 

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