Quality Assurance Analyst

Job Title: Quality Assurance Specialist

Job Description

As a Quality Assurance Specialist, you will provide direct manufacturing Quality Assurance support for all GMP activities. You will be a key Quality contact to manufacturing for discrepancy management, batch review, and line support, ensuring compliance with cGMP regulations and applicable standards. You will be expected to work independently, resolving Quality Assurance issues and developing solutions for complex problems in line with cGMP regulations. You will also play a vital role in maintaining a state of inspection readiness, reviewing batch records, interacting with interdepartmental contacts on discrepancy assessment and resolution, and supporting process improvement initiatives. Advocacy for diversity, equity, and inclusion is an integral part of our mission.

Hard Skills

1. Quality Assurance
2. cGMP regulations
3. Discrepancy management
4. Batch review
5. Inspection readiness
6. Document review and approval
7. Process improvement support
8. Drug product manufacturing
9. Pharmaceutical
10. Biotech
11. Quality manufacturing

Soft Skills

1. Problem solving
2. Interdepartmental collaboration
3. Advocacy for diversity, equity, and inclusion

Job Type

This is a contract position with a duration of 12 Month(s).

Work Site

This is a fully on-site position in Hillsboro, Oregon.