Quality Assurance Associate II/III -Quality Management System
Serán BioScienceBend, Oregon, United States
Posted May 22, 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 searching for an experienced Quality Assurance Associate to support quality systems programs. Tasks include supporting quality system programs, assisting in the maintenance of the electronic Quality Management System, conducting risk analyses and investigations, and participating in audits and inspections.
Requirements
- Supports the implementation and continuous improvement of the company's Quality systems
- Assists in monitoring of Serán quality systems through trending and metrics analysis
- Supports the management of Serán's quality systems through program oversight and eQMS administrative functions
- Document authorship, review, and approval of SOPs, reports, and quality records
- Oversight of investigation and CAPA program management
- Supports internal audits, client audits and regulatory inspections, as needed
Benefits
- Paid Time Off
- Retirement Plan
- Health Plans
- Basic Life Insurance
- Long-term Disability Insurance
- Employee Assistance Program
- Pet Insurance