Senior Quality Assurance Associate (Canada)
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Responsible to support the development implementation maintenance and monitoring of Quality Management Systems (QMS) and activities in the execution of Quality Assurance Deliverables. Responsible for supporting the business in Quality Assurance through audit activities in support of ongoing quality improvement. Acts as a liaison with other business units and partners and assumes some responsibilities for Quality led initiatives based upon knowledge of regulations standards and industry best practices.
Quality Assurance Implementation (70-75%)
- Executes assigned actions related to the corporate Quality Plan.
- Provides guidance to eQMS modules users.
- Reviews and approves document change requests and CAPAs submitted by internal stakeholders.
- Liaises with internal stakeholders to facilitate the development/revision and review of QMS documents (SOPs Work Instructions Associated Documents) Root Cause Analysis/CAPAs and training materials as required.
- Leads improvement initiatives for quality processes against corporate standards and regulatory requirements.
- Supports audits (internal site vendor) and associated Corrective Action and Preventive Actions (CAPAs).
- Provides guidance as required to internal stakeholders related to the interpretation of GCP and regulatory requirements.
Regulatory Ethical Conduct and Audit Monitoring (10-15%)
- Remains current on and communicates changes to relevant regulatory requirements and industry standards.
- Assists in the identification of process changes to QMS documents and/or training requirements to meet regulations standards and sponsor expectations.
- Supports Sponsor and regulatory inspections or audit activities.
Quality Assurance Training
- Identifies creates adapts and delivers quality assurance orientation as well as department project team and clinical site quality assurance training programs.
- Initiates training plan creation and manages the training database.
- Liaises with Human Resources to communicate training assignments.
Qualifications
- The successful candidate will possess either an undergraduate degree with 1-3 years of related experience and on the go training or a College Diploma with 4-6 years of related experience and training.
- Clinical Research Quality Assurance or Information Technology experience preferred. Analytical critical thinking problem solving and attention to detail skills required. Strong computer skills required. Basic knowledge of ICH GCP and global regulations governing Clinical Research.
$61000 - $102000 a year
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Required Experience:
Senior IC
Key Skills
- Administrative Skills
- Core Java
- Glass
- Administration Support
- Database Administration
- Import & Export
About Company
Accelerate your GI clinical trials with Alimentiv’s site network, clinical trial services, medical imaging, and biomarker discovery
