Quality Assurance Engineer
Serán BioScienceBend, Oregon, United States
Posted March 24, 2026
Full Time
About the Company
Serán BioScience is a CDMO focused on optimizing drug development and manufacturing from discovery to clinical trials. With expertise in delivery of poorly soluble compounds, they utilize novel technologies like spray drying, hot melt extrusion, and nanoparticle formulations to enhance solubility and bioavailability. Their custom-built equipment and broad range of services ensure high-quality pharmaceuticals that meet regulatory standards.
Job Description
Serán BioScience is seeking a Quality Assurance Engineer with industry experience to join its cross-functional team. The QA Engineer will be responsible for reviewing and approving qualification/validation of lifecycle activities associated with facilities, utilities, equipment, process, cleaning, and computerized systems.
Requirements
- Generates and/or supports the generation of risk assessments, user requirements specifications (URS), C&Q plans, change controls, SOPs, CAPAs, and other relevant documents
- Supports validation lifecycle activities such as, but not limited to, change management, periodic reviews, and re-qualification to ensure that qualified systems remain in their validated state
- Makes compliance decisions to support commercial operations
- Mentors colleagues on the reasons or justifications of the requirements and practices
- Drives process improvement initiatives
- Provides support during clients and regulatory audits
Benefits
- Over four weeks of paid time off annually
- Employer contributions to a retirement account
- Various health plans with minimal employee contributions
- Basic life and long-term disability insurance
- Employee Assistance Program
- Pet insurance
