Quality Assurance

Job Titles

  • Quality Assurance Associate
  • QA Associate
  • Document Reviewer

Educational Background

  • B.Sc.

Job Functions

  • Quality Oversight
  • Deviation handling
  • Documents and review
  • Audit

Note: You could be a QA associate for the QC lab, R&D lab, manufacturing or other but they all have these common job functions

Quality Oversight

  • Make sure quality system is in place and is being followed
  • Ensure company’s standard operating procedures and regulatory regulations are strictly followed and enforced.
  • Ensure controls are in place
  • Participate in the department’s continuous improvement projects related to Quality Systems, Processes and Procedures

Deviation handling

  • Initiate and manage change control or Corrective Action Preventative Action (CAPA) requests and ensure these requests are closed on time
  • Initiate CAPA’s for deviations, customer complaints (adverse reactions/ product related complaints), audits, etc. If you are a senior associate, you will be involved in the decisions makings towards product recalls and customer complaints related
  • Ensure CAPA’s root cause analysis, corrective actions and preventative actions have have good justification
  • Review Lab Investigation Reports (LIR) for QA approval and provide input as needed

Documents and Review

  • Writes/ reviews / updates Standard Operating Procedures (SOPs) through change control system.
  • Write reports such as deviation/ incident reports, investigation reports, internal audit report and product recall report.
  • Reviews for compliance and approves results/data, documents, test methods, validation reports, protocols and etc.
  • Release out of service equipments for use after reviewing and approving the appropriate calibration/ verification/ qualification data

Audit

  • Conduct self inspection of the GMP (Good Manufacturing Practices) areas and activities for compliance with GMP and company standard operating procedures
  • Performs supplier/vendor audits and contract lab audits
  • Participate in the regulatory audits
    • Coordinate and prepare for the audit
    • Be part of the team interacting with the auditors during the audit
    • Write up response for audit findings

Other Duties

  • Guide, coach and direct GMP staff with respect to quality issues and concerns
  • Update and maintain QA database
  • Continuously evaluate quality control methods, policies, etc. and makes recommendations for improvement
  • Conducts staff training as needed such as annual GMP refresher training
  • Ensures employees are completing the required training, including SOP training and follow up with them if needed.
  • Assess procedures currently in place for compliance and identify gaps and make necessary recommendations for improvement.

Must Have Skills

  • Exceptional attention to detail and accuracy
  • Strong written and oral communication skills.
  • Excellent organizational and time management skills
  • Ability to meet deadlines, train and coach, solve problems.
  • Able to interact with all levels within the organization
  • Able to work in a highly regulated environment and strictly follow company Standard Operating Procedures (SOPs), regulatory guidelines and safety standards.
  • Honest and transparent
  • Able to make decisions and a fast learner
  • Work as part of a team and individually

Type of companies that hire

  • Pharmaceutical/ Biopharmaceutical
  • Regulatory Agencies (Health Canada)
  • Biotech
  • Contract Labs
  • Medical Device Companies
  • Cannabis Industry
  • Food Industry
  • Cosmetic companies
  • other

Competitive Advantage

certificate/ diploma or even a course taken on Quality Assurance

Career Growth

Associate –> Senior –> Supervisor / Manager –> Director

Other options:

–> regulatory auditor. For example, you could apply to Health Canada (if Canadian citizen) or FDA (if US citizen) to become an Auditor who audits the pharmaceutical companies and such for compliance. (it involves constant traveling)

–> Once at manager/ director level, you could become a consultant or open your own consulting company

Recommended Readings

  1. Quality Systems Approach to Pharmaceutical CGMP Regulations (FDA)
  2. Pharmaceutical Quality Systems: US Perspective
  3. Guide to Inspection of Pharmaceutical Quality Control Laboratories (FDA)
  4. Quality assurance of pharmaceuticals (World Health Organization, 2007)