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Quality Assurance Associate
Quality Assurance AssociateAuxilium Health • Oshawa, ON, Canada
Quality Assurance Associate

Quality Assurance Associate

Auxilium Health • Oshawa, ON, Canada
Il y a 4 jours
Type de contrat
  • Temps plein
  • Permanent
Description de poste

Job Description

Job Description

#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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