Quality Assurance Associate

5 days ago

Edmonton, Canada Gilead Sciences Full time

For Current Gilead Employees and Contractors:
**Job Description**:
This role requires working effectively in a multi-disciplinary team on semi routine tasks while exercising judgment within well-defined practices and policies.

Critical thinking and good judgment is required in resolving problems and make routine recommendations.

Essential Duties & Job Functions:
- Performs Quality Assurance tasks that supports GMP-compliant operations in an API manufacturing facility.- Interacts with Operations personnel to complete routine work as well as resolution of non-routine issues.- Performs detailed reviews of documentation related to materials management and batch disposition.- Assists to maintain documentation and records in the documentation system.- Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs).- Participates in continuous improvement initiatives based on international regulations and industry best practices.- Prioritizing tasks to ensure the critical tasks are completed on time and meet requirements.- Authors changes to procedures, work instructions, or other controlled documents relating to material management.- Participates in site inspection readiness and the site internal audit program, including site walkthroughs.- Supports site risk management activities, including participating in risk assessments to support quality systems.

Knowledge, Experience and Skills:
- A BS or BA degree in a scientific area required- Must be able to think critically and creatively, be able to work independently, determine appropriate resources for resolution of problems, and have strong organizational and planning skills.- Demonstrates excellent communication (verbal and technical writing) skills and strong interpersonal skills.

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