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Quality Assurance Engineer

Serán BioScienceBend, Oregon
On-site Full-time

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Experience Level

Experience

Qualifications

Candidates should have a proven track record in Quality Assurance within the biotechnology or pharmaceutical industry. A thorough understanding of regulatory compliance and quality management systems is essential. Strong communication skills and the ability to work collaboratively in a team-oriented environment are required.

About the job

Join Serán BioScience, a dynamic and growing company, as a Quality Assurance Engineer. This is an exciting opportunity to contribute to our expanding team, where you will play a crucial role in ensuring the quality and compliance of our Commercial Manufacturing Facility. As a QA Engineer, you will collaborate with cross-functional teams to review and approve qualification and validation processes related to our facilities, utilities, equipment, processes, cleaning, and computerized systems.
 
Your expertise will be vital in facilitating effective communication between internal and external teams, ensuring alignment on quality strategies, and addressing any deficiencies while fostering positive relationships. Candidates should possess a solid understanding of current regulations and guidelines, including but not limited to 21 CFR Parts 11, 210, and 211, EudraLex Volume 4, Annex 15, and GAMP 5.

About Serán BioScience

Serán BioScience is a leading biotechnology company dedicated to advancing health solutions through innovative scientific research and high-quality manufacturing practices. We are committed to excellence and continuous improvement as we expand our operations.

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