This experienced position requires a sound understanding of quality assurance systems, methods, and procedures. The candidate will lead product complaint investigations, including coordinating the different investigation elements with site departments, conducting a detailed review of complaint samples against master files to determine authenticity, investigating root causes, and implementing corrective and preventive actions.
Job Responsibilities
• Lead customer complaint investigation coordination and work directly with site departments for timely completion of investigations.
• Conduct a detailed review of complaint samples against master files and retain samples to determine authenticity.
• Serve as a lead/coordinator of investigations in summarizing the investigation outcome and corrective and preventive action (CAPA) recommendations related to manufactured products.
• Participate in developing Standard Operating Procedures (SOPs) to ensure quality objectives are met.
• Perform a wide variety of activities to ensure compliance with applicable regulatory requirements.
• Maintain routine programs and processes to ensure high-quality products and compliance with current Good Manufacturing Practices (GMPs).
• Typically receives very little instruction on routine work, general instructions on new assignments.
Knowledge and Skills Required
• Demonstrates working knowledge of current Good Manufacturing Practices (GMPs)
• Demonstrates working knowledge of quality assurance systems, methods, and procedures.
• Demonstrates knowledge of FDA/EMEA standards and quality systems.
• Demonstrates basic knowledge of six sigma, LEAN, and root cause analysis tools used for identifying and correcting deviations.
• Demonstrates audit and investigation skills, and report writing skills.
• Demonstrates good verbal, written, and interpersonal communication skills.
• Demonstrates proficiency in Microsoft Office applications.
Typical Education and Experience
• 4+ years of relevant experience in a GMP environment-related field and a BS degree.
• 2+ years of relevant experience and an MS degree.
• Prior experience in the pharmaceutical industry is preferred.