Manager, Quality Control

Responsibilities

• Complete tasks as required (in a timely manner), compliant with cGMP, regulatory and corporate requirements and conform to Health, Safety & Environmental responsibilities
• Mentor chemists and analysts
• Write, review, revise and approve: Standard Operating Procedures (i.e. Laboratory Procedures)
• Project Progress Reports
• Project Timelines
• Acceptance Methods
• Test Data (Summary Results)
• Conduct and appropriately document laboratory investigations
• Write, review and direct the execution of analytical protocols
• Manage computer system validation (CSV) activities for analytical equipment/instruments
• Demonstrate success in technical proficiency, scientific creativity, independent thought, and collaboration with others
• Demonstrate analytical problem-solving skills
• Conduct data analysis using a wide range of scientific and statistical tools
• Troubleshoot and resolve complex issues
• Demonstrate high ethical standards
• Possess analytical instrument trouble shooting skills
• Possess excellent oral and written communication skills
• Possess multi-tasking ability and the ability to effectively prioritize projects
• Observe and communicate trends and develop “continuous improvement” plans
• Act as a technical liaison with customers to define objectives of projects and provide written/verbal reports on progress
• Possess analytical instrument repair knowledge and ability
• Read/interpret SOPs to ensure compliance
• Maintain a robust training program designed to demonstrate proficiency in analytical techniques
• Other duties as assigned

Requirements

• Bachelor’s Degree in in Science, Chemistry, Biology or related field of study
• Minimum of five (5) years in Analytical Chemistry, Quality Assurance or Regulatory Compliance Management
• Minimum of two (2) years in a leadership role
• Minimum of five (5) years in an aseptic/sterile product facility, preferred
• Supervisory Responsibilities

Qualifications

• Must pass a background check
• Must pass a drug screen
• May be required to pass Occupational Health Screening
• May be required to obtain and maintain gowning certification
• May be required to obtain and maintain media qualification