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

Career Growth

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