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(Canada) Quality Assurance Associate
Company | Vial |
Address | Canada |
Employment type | FULL_TIME |
Salary | |
Category | Biotechnology Research |
Expires | 2023-05-12 |
Posted at | 1 year ago |
Who We Are
- Reporting, managing, and following deviations, complaints, issues, non-conformances, and their related CAPAs
- Assisting in the creation, review, revision, and management of procedural documents
- Preparing audit plans for individual audits
- Assisting in the preparation, coordination, documentation, and follow-up of regulatory inspections
- Evaluating internal compliance with company procedures, policies, programs, initiatives, GCP, and applicable regulations (internal systems and process audits)
- Clearly communicating and reporting (verbally and in writing) audit outcomes and escalating significant compliance concerns to project teams, QA and management and client contacts appropriately
- Maintaining working knowledge of regulatory requirements, ICH GCP principles, and clinical trial processes
- BA/BS in life sciences, social sciences, or a related degree; at least 3 months experience actively supporting clinical research(Experience can be credited for degree)
- Ability to maintain high level of accuracy and attention to detail
- The candidate must be able to work independently and as a member of a team
- Good analytical and organizational skills
- Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment
- Ability to prioritize, be organized and detail-oriented, and demonstrate strong analytical skills
- Must possess strong Excel, Word, and PowerPoint skills
- Prior QA experience supporting professional services within CRO
- Possess a working knowledge of and experience with GCP
- Must be a team player with integrity, a commitment to quality, and the ability to think critically and creatively
- Independently motivated, detail oriented and good problem solving ability
- Ability to make a decision in a timely manner
- Must exhibit professionalism
- Ability to demonstrate strong verbal and written communication skills as well as the ability to understand and coordinate multiple projects
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