Complaints Specialist

Support IVC’s mission, vision, core values and customer service philosophy. Primary responsibilities include working with various departments and the complaint team to investigate and respond to reported contract customer complaints and ensure closure in a timely manner. Writing technical responses to customers and assessing product impact of various complaints. Review of batch records and retain samples as necessary for complaint investigations. Lead and manage activities for complaint related CAPAs and develop trend reports to report to upper management.

• Adhere and ensure compliance to the Standard Operating Procedure on Complaints when handling a complaint for manufactured and distributed products as required by applicable regulations, standards, and company policy.
• Use critical thinking skills to determine needed course of action and resolve complaints with appropriate tone, content and direction.
• Draft technical responses that include recording detailed notes and information into the investigation report and attach in complaint data base.
• Request and review batch records and retains as necessary to complete complaint investigations;
• Request QC analysis as applicable to complete investigations.
• Interfaces with contract customers on the retrieval of complaint samples and gathering of additional information required for complaint investigations.
• Immediately communicate any complaints received that need to be escalated to department management.
• Work with the other complaint specialist, as a team, to gather needed information for investigations.
• Ensure that complaints, as a department, are closed in a timely manner.
• Complete assignments efficiently.
• Create and develop periodic trend reports to communicate to management.
• On a monthly basis, provide open status and summary of issues that are resulting in delays of complaint investigation(s).
• Report all serious adverse events to Quality Management and others as specified in the Standard Operating Procedure on Complaints.
• Partners and communicates with applicable departments on product investigations and trends.
• Actively participate in department process improvement efforts.
• Strong understanding of root cause analysis and processes
• Request and follow up on required Root Cause, Corrective and Preventive Action Plans to address a customer complaint from the appropriate department. Follow up on implementation of CAPA Plans as needed.
• Ability to interact and coordinate with various departments and skill levels in a professional and consistent manner related to complaint investigations.
• Ability to follow written and verbal policies and procedures.
• Various duties, roles and task as deemed necessary by Sr. Manager of Consumer Affairs or designee.
• Strong team player who can work independently and under limited supervision.

• Preferred four-year degree in Science or related field or a two-year degree with 3-5 years of experience in a GMP facility (food, dietary supplement, pharmaceutical).
• Preferred complaint investigation experience or specialized quality training such as ASQ certification and other industry related education.
• Excellent verbal and written communication skills including a high degree of professionalism when communicating to internal and external customers.
• Strong interpersonal skills, excellent attention to detail and high organizational skills.
• Must be a self-starter and able to work independently in a fast-paced, dynamic, team environment.
• Ability to quickly access and retrieve information using a PC and basic understanding of Microsoft Office products (Excel, Word, and Outlook).