Bioscience

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

Critical Work Functions

• 4.4.1 Monitor, inspect, and verify quality of the product, procedure, or specimen to ensure compliance with standards and specifications

• 4.4.2 Develop, install, and revise validation procedures and protocols

• 4.4.3 Control and maintain documentation about qualification and validation

• 4.4.4 Calibrate and validate equipment systems and assess equipment performance

• 4.4.5 Revise and update standard operating procedures

• 4.4.6 Take and document corrective and preventive action according to Standard Operating Procedures or as directed

• 4.4.7 Know and comply with current federal, state, local, and industry regulations

• 4.4.8 Participate in compliance training

• 4.4.9 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

• 4.4.10 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