Quality Specialist l

Implements and administers quality programs in accordance with applicable requirements, Standard Operating Procedures (SOPs), Good Laboratory Practices (GLPs), current Good Manufacturing Practices (cGMPs) and in compliance of ISO/IEC 17025:2005 to ensure integrity and consistency of quality systems and training. 

Essential Duties and Responsibilities:

• Quality Specialist may perform as acting Quality Manager as required. 
• Coordinates with multiple locations, units, and/or cost centers
• Conducts internal audits
• Determines SOP applicability
• Peer reviews SOPs and other controlled documents
• Identifies and participates in process improvements
• Evaluates responses to inspection reports
• Participates in external audits
• Implements and monitors compliance with SOPs
• Defines, maintains, and implements new employee training SOP
• Participates in development of training programs
• Monitors control charts
• Reviews methods for completeness and compliance
• Performs other related duties as assigned