- Senior
- Optionales Büro in Oshawa
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POSITION Senior 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 Senior Quality Assurance Associate is responsible for supporting the development, maintenance and continuous improvement of the organization’s Quality Management System (QMS). This role involves leading quality initiatives and overseeing core processes to ensure the organization’s compliance with regulatory requirements, quality standards and internal policies.
GENERAL RESPONSIBILITIES AND ESSENTIAL FUNCTIONS:
QUALIFICATIONS:
EDUCATION AND EXPERIENCE:
WORKING CONDITIONS:
JOB DESCRIPTION
POSITION Senior 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 Senior Quality Assurance Associate is responsible for supporting the development, maintenance and continuous improvement of the organization’s Quality Management System (QMS). This role involves leading quality initiatives and overseeing core processes to ensure the organization’s compliance with regulatory requirements, quality standards and internal policies.
GENERAL RESPONSIBILITIES AND ESSENTIAL FUNCTIONS:
- Function as an administrator of the organization’s electronic Quality Management System (eQMS), including overseeing Quality Records, managing users, and applying system updates and bug fixes.
- Lead and manage quality-related projects, including implementing process improvements and driving compliance initiatives.
- Assist with the monitoring of Key Performance Indicators (KPIs) associated with the QMS.
- Liaise with stakeholders to provide guidance on quality objectives.
- Maintain Standard Operating Procedures (SOPs) and Work Instructions (WORs), including development, modification, and approval.
- Assist with the initiation, execution and approval of Deviations, Complaints, Change Controls and Corrective and Preventative Actions (CAPAs).
- Assist with the oversight of the organization’s Audit, Supplier and Equipment Maintenance programs.
- Assist with day-to-day Quality Assurance activities, including review and approval of Laboratory Reports and distribution records.
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 managing a QMS, including experience with overseeing quality processes such as Deviations, Complaints, Change Controls, CAPAs, Audits, Supplier Management and Equipment Maintenance.
- Experience with leading quality-related projects and implementing process improvements.
- Strong knowledge of regulatory requirements, quality standards and industry best practices.
- 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.
- 3-5 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.
