Product Quality Complaints Analyst
Where
- Fort Washington, PA
What you'll be doing
- The product quality complaint analyst is responsible for administration of the customer complaint management system, collecting, monitoring, trending, prioritizing, coordinating investigations and responding to customer complaints related to the company products in a timely manner and in compliance with current good manufacturing practices (cGMP) requirements. This individual will perform initial analysis of complaints received by the site for investigation, including manufacturing and packaging records reviews, coordination of field sample inspections and retention, assessment of notification to management requirements and determination of expanded process SME investigation necessity. This individual will collaborate with other complaint analysts, complaint investigators, home office complaint vigilance team and process SMEs to ensure thorough, robust, and timely complaint investigations. Candidate will ensure target cycle times are met and provide data analysis for complaint metrics and trending. Additional responsibilities of this position include determine which complaints require an expanded process SME investigation and refer those complaints to the appropriate investigator. Provide and analyze data as required for complaint metrics and trending, including but not limited to APRs and site quality councils. Manage the inspection and retention of consumer complaint samples.
What your background should be
- Minimum 2 years experience in the pharmaceutical industry or other highly regulated industry is required. Strong verbal and written communication skills are required for this role. The ability to prioritize, influences, and negotiate without direct line authority is required. The ability to operate in a high pressure environment under tight time constraints and to understand and follow complex processes is required. Advanced experience with Excel and Minitab is preferred.
Required Schooling / Training
- Bachelor degree is required.
Who is the client company
- This is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer company.
- If you are interested in this position, send your resume to apply@kochdavis.com
