Quality Assurance Associate

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JOB DESCRIPTION

POSITION Quality Assurance Associate
COMPANY AND LOCATION Stratum Canada, Oshawa, ON
EMPLOYMENT TYPE Permanent, Full- time
HOURS WORKED 37.5 hours/week

POSITION SUMMARY:

The Quality Assurance Associate is responsible for executing activities within the scope of the organization’s Quality Management System (QMS) and supporting the organization’s compliance with regulatory requirements, quality standards and internal policies.

GENERAL RESPONSIBILITIES AND ESSENTIAL FUNCTIONS:

• Perform review and approval of Laboratory reports and distribution records.
• Maintain Standard Operating Procedures (SOPs) and Work Instructions (WORs), including development, modification, and approval.
• Perform the initiation, execution and approval of Quality Records, including Deviations, Complaints, Change Controls and Corrective and Preventative Actions (CAPAs).
• Assist with the execution of the organization’s Audit, Supplier and Equipment Maintenance   programs.
• Complete quality-related projects, including implementing process improvements and driving compliance initiatives.

​​​​​​​​​​​​​​ QUALIFICATIONS:

• Experience with Good Manufacturing Practices (GMPs) and Good Documentation Practices (GDPs).
• Knowledge of ISO 9001, ISO 13485 and ISO 17025 preferred.
• Experience with SOPs and quality documentation.
• Experience with a 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’s degree in Science, 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.

​​​​​​​ DISCLAIMER
The job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned at any time with or without notice.

OUR RECRUITMENT PROCESS:

• Application and Questionnaire - Candidates submit an application and complete the initial questionnaire.
• Pre-Screen Video Interview - Qualified candidates will be invited within one week to complete a short one-way video pre-screen.
• In-Person Interview - Shortlisted candidates will be invited to attend an in-person interview at our head office.
• Offer and Background Check - The successful candidate will be offered the position, pending a criminal background check and references.

We appreciate the applications from all candidates, but only those selected for the next steps will be contacted.

Stratum Canada is an equal opportunity employer. We welcome diversity and are committed to creating an inclusive environment for all employees. Accommodations are available on request for candidates taking part in all aspects of the selection process.

This position is being posted to fill an existing vacancy within our team.