Quality Assurance Engineer

Serán BioScience(24 days ago)

Bend, OROnsiteFull TimeMedior$92,891 - $124,771 (estimated)Quality Assurance

About this role

The Quality Assurance Engineer at Serán BioScience supports qualification and validation activities across facilities, utilities, equipment, processes, cleaning, and computerized systems in a commercial pharmaceutical manufacturing environment. The role sits within a cross-functional team and focuses on ensuring systems remain in a validated state in compliance with applicable regulations and guidelines. It involves close collaboration with internal and external stakeholders and contributing to a growing commercial manufacturing facility in Bend, Oregon. The position emphasizes strong documentation, regulatory understanding, and support during audits and inspections.

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Required Skills

Risk Assessment
User Requirements
Change Control
SOP Development
CAPA Management
Validation Lifecycle
Change Management
Periodic Review
Requalification Support
Compliance Decisions

+19 more

Qualifications

Bachelor’s degree in a science
Bachelor’s degree in engineering

About Serán BioScience

seranbio.com

Serán Bioscience is a science-driven drug development company that uses a research-first approach and advanced drug‑delivery technologies to enable and enhance clients’ medicines. They partner with biotech and pharmaceutical teams to translate therapies from concept toward clinical readiness, focusing on formulation and delivery solutions that improve patient outcomes. Headquartered in Bend, Oregon, Serán emphasizes rigorous science and collaborative development to accelerate programs and de‑risk therapeutic candidates.