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Quality Control and Assurance

Practicing quality control and assurance, and operating under governmental regulations.

Critical Work Functions

  • Monitor, inspect, and verify quality of the product, procedure, or specimen to ensure compliance with standards and specifications
    • Develop, install, and revise validation procedures and protocols
      • Control and maintain documentation about qualification and validation
        • Calibrate and validate equipment systems and assess equipment performance
          • Revise and update standard operating procedures
            • Take and document corrective and preventive action according to Standard Operating Procedures or as directed
              • Know and comply with current federal, state, local, and industry regulations
                • Participate in compliance training
                  Technical Content Areas

                  • Quality Control/Quality Assurance
                    • Continuous Improvement
                    • Audits
                    • Validation Testing
                    • Documentation
                    • Product Specifications
                    • Statistical and Data Analysis
                    • Inventory Management
                    • Test Standards and Controls
                    • Quality Assurance Logs
                    • Standard Operating Procedures
                    • Proficiency Testing
                    • Plant or Material Flow
                  • Regulatory Compliance
                    • Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP)
                    • Federal Regulatory Agencies (including but not limited to):
                      • U.S. Food and Drug Administration (FDA)
                      • U.S. Department of Agriculture (USDA)
                      • National Institutes of Health (NIH)
                      • National Research Council (NRC)
                      • Department of Transportation (DOT)
                      • Center for Disease Control and Prevention (CDC)
                      • Nuclear Regulatory Commission (NRC)
                      • Clinical Laboratory Improvement Amendments (CLIA)
                    • State and Local Regulations
                    • Industry and Professional Regulations