This experienced position requires requiring sound knowledge of quality assurance systems, methods and procedures. The candidate will lead product complaint investigations including coordinating the different investigation elements with site departments, completing detailed review of complaint samples against master files to determine authenticity, investigating, root cause and corrective/preventive actions. In addition, the candidate will be involved in general quality system support activities related to the complaints process such as documentation update and review for changes and efficiency improvements

TYPICAL EDUCATION AND EXPERIENCE

• 4+ years of relevant experience in a GMP environment related field and a BS.
• 2 + years of relevant experience and a MS.
• Prior experience in pharmaceutical industry is preferred.

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

• Lead customer complaint investigation coordination and working directly with site departments for timely completion of investigations.
• Complete 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.
• Participates in developing Standard Operating Procedures (SOPs) to ensure quality objectives are met.
• Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
• Maintains routine programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs).
• Normally 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.