Senior Quality Control Engineer

$74,000 - $74,000/Yr

Mayo Clinic - Rochester, MN

Full-time - Mid Level

Rochester, MN

Hospitals

About the position

The Senior Quality Control Engineer at Mayo Clinic's Center for Regenerative Biotherapeutics (CRB) plays a crucial role in ensuring the quality and safety of biologics and cell therapy products. This position requires a strong background in microbiology and experience in a cGMP-regulated environment, focusing on microbiological testing, environmental monitoring, and compliance with regulatory standards. The engineer will be responsible for data reporting, assay development, and maintaining high standards of documentation and data integrity.

Responsibilities

• Trending, reviewing, and writing environmental monitoring data reports for the facility.
• Assisting with the scheduling and monitoring of routine and non-routine microbiological testing of materials and cell therapy products.
• Performing quality control assays including release, in-process, and stability testing.
• Supporting assay development and validation processes.
• Performing all GMP-related activities according to SOPs with accurate documentation in compliance with cGMP and data integrity principles.

Requirements

• A master's degree in a biomedical related field with at least 2 years of research experience, or a bachelor's degree with a minimum of 5 years relevant experience.
• Experience in a cGMP environment, particularly in clinical manufacturing of biologics or products intended for human use.
• Strong technical understanding and experience in developing assays.
• Ability to analyze data and compose reports effectively.
• Exceptional communication skills to convey complex ideas to various stakeholders.

Nice-to-haves

• Experience with microbiological testing, environmental monitoring, and knowledge of sterility, bioburden, and endotoxin testing principles.
• Flexibility to adapt to changing work schedules and customer needs.

Benefits

• Competitive compensation
• Comprehensive benefit plans
• Continuing education and advancement opportunities