Description

Key Responsibilities

• Serve as the site CAPA coordinator and administrator for shipment temperature management.
• Act as the primary quality interface for FDA, supplier, customer, and corporate audits and inspections.
• Manage projects supporting quality and compliance initiatives.
• Maintain and manage the validation document library.
• Conduct investigations involving product quality complaints, product diversion, and distribution-related concerns.
• Manage the warehouse temperature monitoring program.
• Serve as the primary Quality Assurance contact for new product introduction (NPI) launches.
• Execute the placement and removal of QA holds within the warehouse management system.
• Manage and post supplier audit information in the appropriate quality database.
• Manage market authorization activities and Master Data Management processes.
• Analyze complex technical data related to product acceptance and compliance.
• Collaborate with R&D, Process Development, Manufacturing, Operations, Distribution, and Engineering to resolve product and process issues.

Qualifications

• Bachelor’s degree preferred.
• At least four years of experience in Quality Assurance, process support, engineering, manufacturing, operations, distribution, or a related area.
• Knowledge of cGMP, cGDP, manufacturing, and distribution processes.
• Experience reviewing deviations, investigating problems, and evaluating compliance concerns.
• Experience supporting product compliance and troubleshooting activities.
• Experience serving as a quality representative during audits or inspections.
• Ability to analyze complex technical data and make sound product acceptance decisions.
• Strong problem-solving skills and creativity in resolving quality and operational issues.
• Effective negotiation and relationship-management skills when working with manufacturing and distribution stakeholders.
• Ability to collaborate across R&D, Process Development, Manufacturing, Operations, Distribution, and Engineering teams

Key Skills

Education

Bachelor's degree