Full-Time Quality Assurance Associate
Alimentiv 2 is hiring a remote Full-Time Quality Assurance Associate. The career level for this job opening is Entry Level and is accepting Canada based applicants remotely. Read complete job description before applying.
Alimentiv 2
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Quality Assurance Associate
Job Description
Support development, implementation, maintenance, and monitoring of Quality Management Systems (QMS) and activities related to Quality Assurance Deliverables.
Support business quality assurance through audit activities and ongoing quality improvement.
Act as liaison with other business units and partners, and take on responsibilities for Quality-led initiatives, based on knowledge of regulations, standards, and industry best practices.
Quality Assurance Implementation
Execute assigned actions related to the corporate Quality Plan.
Liaise with internal stakeholders to facilitate the development/revision and review of QMS, SOPs, Work Instructions, Associated Documents, standards, and training materials.
Evaluate quality processes against corporate standards and regulatory requirements.
Support audits (internal, site, vendor) and reviews associated Corrective Action and Preventive Actions (CAPA’s).
Provide guidance to internal stakeholders on the interpretation of GCP and regulatory requirements.
Regulatory, Ethical Conduct and Audit Monitoring
Stay current on and communicate changes to relevant regulatory requirements and industry standards.
Assist in identifying process changes to QMS documents and/or training requirements to meet regulations, standards, and sponsor expectations.
Support Sponsor and regulatory inspections or audit activities.
Quality Assurance Training
Identify, create, adapt, and deliver quality assurance orientation, department, project team, and clinical site quality assurance training programs.
Initiate training plan creation and manage the training database.
Liaise with Human Resources to communicate training assignments.
Qualifications
Undergraduate degree with 1-3 years of related experience and on-the-go training; or College Diploma with 4-6 years of related experience and training.
Preferred experience: Clinical Research, Quality Assurance or Information Technology experience.
Required skills: Analytical, critical thinking, problem-solving, attention to detail, strong computer skills.
Basic knowledge of: ICH GCP and global regulations governing Clinical Research.