About the role

Serán BioScience is expanding and looking for a Quality Assurance Engineer with industry experience to join at this exciting time. The QA Engineer will be part of a cross functional team that will be responsible for the review and/or approval of qualification/validation of all the lifecycle activities associated with facilities, utilities, equipment, process, cleaning, and computerized systems. The focus of this position will be to support the Commercial Manufacturing Facility that is currently underway.

The development and execution of these deliverables requires direct communication with internal and external cross functional teams. Successful candidates will understand that effective communication is essential for alignment on strategies and approaches, and correcting deficiencies while maintaining good working relationships. Qualified candidates will have a thorough understanding of current regulations and guidelines such as but not limited to 21 CFR Parts 11, 210, and 211, EudraLex Volume 4, Annex 15, and GAMP 5 is required.

Skills & Tags

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Aplyr's read

Serán BioScience is a dynamic biotechnology firm innovating in diagnostics and therapeutics, attracting a diverse workforce from scientists to business developers.
Synthesized from recent postings & public sources

What's promising

•Strong focus on developing cutting-edge diagnostics and therapeutics.
•Recent hiring across diverse roles indicates growth and expansion.
•Opportunities for career advancement in a specialized biotech field.

What to watch

•Biotechnology sector can be volatile and subject to regulatory changes.
•Limited public information about financial stability and long-term viability.
•Highly specialized roles may limit opportunities for generalists.

Why Serán BioScience

•Specializes in both diagnostics and therapeutics, offering a broad scope of innovation.
•Recent expansion into commercial manufacturing suggests strategic growth.
•Emphasis on quality assurance highlights commitment to regulatory compliance.

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About Serán BioScience

Serán BioScience

seranbio.com

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Serán BioScience is a biotechnology company focused on developing innovative solutions for healthcare, particularly in the areas of diagnostics and therapeutics.