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Quality Assurance Engineer at Serán BioScience - ApplyBlast

Quality Assurance Engineer

Serán BioScience

6 months ago

3.8 on Glassdoor

Bend, Oregon, United States

Onsite

Full Time

Medior

0 applicants

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About this role

Serán BioScience is seeking a Quality Assurance Engineer to join the Product Commercialization team and support the Commercial Manufacturing Facility. The role involves reviewing and approving qualification and validation activities for facilities, utilities, equipment, processes, cleaning, and computerized systems, while ensuring compliance with regulations such as 21 CFR Parts 11, 210, 211, EudraLex Volume 4, Annex 15, and GAMP 5.

Responsibilities

Generate risk assessments, URS, and validation documentation
Support validation lifecycle activities including change management and re‑qualification
Provide support during client and regulatory audits

Skills

Qualifications

Bachelor's degree in a science, engineering, or related field

About Serán BioScience

seranbio.com

Headquarters

Bend, Oregon, United States

Company Size

201-500 employees

Founded

2016

View Profile

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.