Career Tracks

Quality Control
  • Chemistry lab- Check for impurities, verify composition of final product
  • Microbiology lab- conduct sterility testing and environmental monitoring
  • Cell biology lab- ensure purity and verify the composition of the final product
  • Animal group- maintain animals for preclinical toxicology studies
  • Environmental monitoring- properly dispose of trash
  • Metrology- calibrate machinery and instruments
Quality Assurance
  • Document and review- handles and reviews paperwork from manufacturing and laboratories
  • Auditing group- monitor products, procedures and systems
  • Prescription drug compliance- ensure prescription drugs purchased by consumers are safe, effective and not counterfeit
Quality Systems
  • Validation (computer validation/IT and more)- establishing documented evidence that a specific process or system will consistently make product
  • Training- train personnel on their job assignments
  • Document management- maintain documents important for regulatory
  • Corrective and preventive action- investigate problems, correct issues and prevent future problems
  • Quality engineering- test systems and applications

Roles and Responsibilities

  • Laboratory testing
  • Validating systems
  • Providing compliance oversight for contract service providers
  • Laboratory compliance
  • Conducting vendor audits
  • Conducting internal audits
  • Hosting inspections/audits from health authorities
  • Document review for product release
  • Good documentation practices
  • Document control, writing and managing SOPs and policies
  • Training employees
  • Regulatory submissions
  • Handling complaints

Are you a good Candidate? 

People who flourish tend to have:
  • Meticulous attention to details
  • A systematic, methodical and organized approach
  • Ability to remain focused on the rules
  • Desire to work in a prescribed work environment
  • Exceptionally good problem-solving skills and ability to handle sudden emergencies and changes
  • Good writing skills 
  • Good presentations and verbal communication skills
  • Diplomacy and tact
  • Excellent interpersonal skills
  • Team oriented attitude
  • Ability to stick to values
  • Time management skills
  • Good listening skills 
  • Service or customer orientation
  • Information- gathering skills
  • Resilience and tenacity
  • General knowledge
  • Knowledge of drug discovery and development process and regulations
  • Ability to be a supportive coach for the success of the organization 

Path to

  • Science background; PhDs may enter at supervisory roles
  • Commonly enter from discovery, preclinical research or chemical development but it depends on subspecialty
  • Commonly have some sort of a clinical background