JOB DESCRIPTION

POSITION Quality Assurance Associate

COMPANY AND LOCATION Stratum Canada, 44 Richmond Street West, Oshawa, ON

EMPLOYMENT TYPE Permanent, Full-time

HOURS WORKED 37.5 hours/week

POSITION SUMMARY:

The Quality Assurance Associate is responsible for providing quality oversight of analytical testing activities through the review and approval of Laboratory Reports, analytical data and associated quality records. The position serves as the primary quality reviewer for laboratory-generated data, ensuring results are accurate, complete, traceable and compliant with applicable regulatory, accreditation and internal quality requirements. The position additionally supports the organization's Quality Management System through participation in document control, change control, investigations, CAPAs, audits, supplier management and continuous improvement activities.

GENERAL RESPONSIBILITIES AND ESSENTIAL FUNCTIONS:

Analytical Data and Report Review:

● Perform review and approval of Laboratory Reports and analytical test results.

● Review worksheets, raw data and supporting documentation for accuracy, completeness and compliance with approved methods and procedures.

● Verify the traceability of analytical results to supporting records and source data.

● Ensure analytical records comply with Good Documentation Practices (GDP) and data integrity requirements.

● Identify and resolve data discrepancies, documentation deficiencies and potential quality concerns prior to report issuance.

● Serve as the final quality reviewer for laboratory-generated reports and client deliverables.

Quality Management System Support:

● Initiate, investigate and manage Deviation, Out of Specification/Out of Trend and Complaint records arising from analytical testing activities.

● Review and approve Change Controls, CAPA records and associated Effectiveness Checks.

● Support root cause analysis related to laboratory operations, analytical testing, equipment performance, supplier management and documentation practices.





● Develop, review and maintain SOPs, Work Instructions, Forms and quality system documents.

● Support compliance with ISO/IEC 17025, ISO/IEC 9001 and other applicable regulatory and accreditation requirements.

● Support training, competency assessment and implementation of quality system improvements.

QUALIFICATIONS:

● Experience with Good Manufacturing Practices (GMPs) and Positive Documentation Practices (GDPs).

● Knowledge of ISO/IEC 9001 and ISO/IEC 17025 preferred.

● Experience with SOPs and quality documentation.

● Experience with a Quality Management System (QMS), including experience with the execution of quality processes such as Deviations, Complaints, Change Controls, CAPAs, Audits, Supplier Management and Equipment Maintenance.

● Knowledge of regulatory requirements, quality standards and industry best practices preferred.

● Excellent communication skills, interpersonal and time-management skills.

● Strong analytical and problem-solving skills.

EDUCATION AND EXPERIENCE:

● Bachelor of Science in Chemistry, Life Sciences or a related discipline.

● 2+ years of experience in Quality Assurance, Regulatory Affairs or Compliance role.

WORKING CONDITIONS:

● Office environment.

● Sitting and working at a computer for several hours of the day.

● Ability to work alone or on a team.

● Ability to work under minimal supervision.

Pay: $50,000.00-$58,000.00 per year

Application question(s):

- Are you legally authorized to work in Canada?
- Do you have a Bachelor's degree in Chemistry, Life Sciences, or a related scientific discipline?
- Do you have at least 2 years of experience in a Quality Assurance, Compliance, or Regulatory Affairs role?
- Do you have experience reviewing analytical data, laboratory reports, raw data, or test results in a regulated environment?
- Have you worked with Quality Management System (QMS) processes such as Deviations, CAPAs, Change Controls, Complaints, or Audits?
- This role is full-time and fully onsite in Oshawa, Ontario. Are you able to work onsite daily?

Work Location: In person

📌 Quality Assurance Associate (Oshawa)
🏢 Stratum
📍 Oshawa