Quality Assurance Product Complaint Specialist I - 1st Shift
About The Position
The Quality Assurance Product Complaint Specialist I assists Quality Management with investigating and resolving customer complaints received through all reporting channels. The role ensures complaints are logged, investigated, and resolved within established deadlines and in accordance with company and GMP requirements. It also supports complaint-related testing, communications, trend analysis, root cause analysis, corrective and preventive actions, regulatory responses, manufacturing investigations, training, document control, audits, and monthly reporting. The position supports workplace safety by following safety procedures and promoting adherence to health and safety requirements and safe behaviors. The work includes regular computer and documentation duties, and may involve production-related ingredients, chemicals, allergens, airborne particles, and potentially hazardous materials. Hearing protection and other protective equipment may be required in loud areas. A flexible schedule, including off shifts and weekends, is required.
Requirements
- Bachelor’s degree from a four-year college or university.
- At least five years of experience in Quality Assurance or Quality Control in the food, pharmaceutical, dietary supplement, or medical device industries handling customer complaint issues, or a combination of education and experience.
- At least three years of experience in root cause analysis.
- Knowledge of GMPs.
- Ability to organize workload and multitask to complete tasks on time.
- Proficiency in Microsoft Office, including Word, Excel, and PowerPoint.
- Excellent written and verbal communication skills, including the ability to write routine reports and correspondence and speak and write effectively.
- Strong mathematical and analytical skills, including ability to work with probability and statistical inference and apply fractions, percentages, ratios, and proportions to practical situations.
- Ability to read and interpret technical procedures and legal or governmental regulations.
- Ability to learn quickly, work independently, and take responsibility for new tasks in a rapidly growing and changing company.
- Ability to interpret instructions provided in written, oral, diagram, or schedule form.
- Self-starter able to handle multiple tasks and communicate and work with others to complete assigned tasks.
- Must be able to work a flexible schedule, including off shifts and weekends.
- Ability to perform regular desk and computer work, use a keyboard, communicate in person and by telephone, and review written documentation for extended periods.
- Ability to meet vision requirements including close, distance, and color vision, peripheral vision, depth perception, and ability to adjust focus.
- Occasionally able to lift up to 25 pounds and walk, stand, reach, and stoop.
Nice To Haves
- Intermediate experience with electronic documentation management system software is preferred.
Responsibilities
- Ensure product complaints are logged, investigated, and resolved according to established deadlines and company and GMP requirements.
- Facilitate testing of reserve or retain samples for investigations.
- Communicate with and provide complaint-related support to Customer Service and the Science Group.
- Create detailed trend analysis reports showing product complaints by category and product.
- Conduct root cause analysis sessions to facilitate and initiate corrective and preventive actions with manufacturing.
- Prepare formal reports responding to adverse event complaints to regulatory authorities.
- Assist with documentation and investigation of manufacturing deviations and non-conformances.
- Assist with GMP training for quality and operations personnel.
- Assist with management of the document control system.
- Assist with regulatory audits.
- Complete pre-audit paperwork for customer audits.
- Compile and submit monthly metrics reports.
- Comply with safety and GMP requirements; follow safety procedures and support workplace safety practices.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
