Quality Assurance Associate
Oshawa, ON, Canada
Full Time
Mid Level
#LI-DNI
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 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.
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