The BioTC exam offers the first standardized assessment tool designed to evaluate a common set of core competencies for entry-level bioscience and biotechnology manufacturing technicians identified with employer input. Subjects covered are listed here.
Calculations
Significant Figures
Scientific Notations
Metric Conversions
Standard Deviations
Measurements
Conversions
Density Measurements
Temperature
General Chemistry Concepts
Solution Preparation
Solubility
Dilutions, Serial Dilutions
Molar, Percent and PPM
Buffers
Atomic Structure and Bonds
Elements
Periodic Table
Compounds
Ionic and Molecular Compounds
Chemical Reactions
Physical and Chemical Properties
Physical and Chemical Changes
Oxidation, Reduction
pH, Acids and Bases
Balancing Chemical Equations
Chemical Safety
Personal Protective Equipment
Storage and Disposal
Housekeeping
Safety Data Sheets
Upstream and Downstream Processing
Types of Chromatography
Instruments Involved
Purification of DNA and Proteins
Instruments Involved
Sterilization and Cleanroom Processing Mechanics
Pumps, Water Purification, Bioreactors, and Compressors
SOP, cGMP, GDP and GLP Requirements
Regulatory Requirements
Regulatory Agencies: FDA, ICH and others
Code of Federal Regulations
Quality Management System and Quality Control
Quality Management System and Quality Control
Process Control
Calibration
Cross-Contamination and Bioburden – Communication Systems
Audits and Inspections
Internal
External
Microbial Growth
Physical and Chemical Requirements
Culture Media Division and Growth Phases
Measurement of Growth
Bioburden
Control of Microbial Growth
Physical and Chemical Methods
Disinfectants
Types and Modes of Action
Classification, Identification & Epidemiology
Types of Bacteria
Gram Stain
Endo and Exo Toxins
Microbial Genetics
Genetics Transcription, Translation
Mutations
Genetic Recombination – Transformation
Transduction
Conjugation
Viruses
Virus Identification
Human Viruses and Control
Bacteriophages
Lytic Cycle
Lysogenic Cycle
Inactivation of Viruses
Pathogens and Bioburden
Health Hazards
Biological Hazards
Physical Hazards
Ergonomics
Toxicity
Safety Hazards
Process Safety
Physical, Chemical & Biological Properties
Personal Protective Equipment
Hazard Controls
Color Coding Waste and Chemicals
Containment
Process and Design
Regulations and Reporting
OSHA and EPA
Others
Validation
Performance
IQ, PQ, OQ
Equipment
Filters, Gaskets, Tubing, Vials
Cleaning
Sterility
Method
Accuracy and Precision
Analytical Analysis
Reproducibility
For additional information on core competencies required for entry-level technician positions in the bioscience and biotechnology industry, please refer to these resources recommended by instructors who help developed the credential’s assessment exam.
John Kenkel, Analytical Chemistry for Technicians, 4th ed., Boca Raton, CRC Press, 2014.
