Quality

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