- Quality Assurance Associate
- QA Associate
- Document Reviewer
- Quality Oversight
- Deviation handling
- Documents and review
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
- 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
- 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
- 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
- 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)
- Contract Labs
- Medical Device Companies
- Cannabis Industry
- Food Industry
- Cosmetic companies