Quality Control Analyst

Overview

We are looking for a dynamic and detail-oriented Quality Control Analyst to join our expanding team. This is a fantastic opportunity for an individual eager to establish a career in Quality Control and biologics manufacturing within a cGMP-regulated environment.

The ideal candidate will engage in analytical testing activities for raw materials, intermediates, and drug substances/products, ensuring compliance with cGMP and regulatory standards. If you have a foundational understanding of biologic therapeutics and are excited to gain hands-on experience in Quality Control, this role is for you!

Experience with cell-based assays and/or PCR-based analyses is highly desirable and will enhance your application.

• Conduct routine analytical testing for GMP manufacturing and assess product quality.
• Execute various assays in molecular, biochemical, and cell-based systems.
• Support testing related to in-process and post-production product quality.
• Maintain laboratory equipment and manage routine reagent usage.
• Accurately track and document samples in alignment with cGMP and Good Documentation Practices (GDP).
• Assist with release assay validation and product stability studies.
• Participate in laboratory housekeeping, calibration, and quality improvement initiatives.
• Uphold high standards of laboratory safety, compliance, and data integrity.
• Collaborate effectively within the QC team and familiarize yourself with systems, methods, and compliance expectations.
• Contribute to additional laboratory and operational needs as required.

• Bachelor's degree in a science-related field.
• A minimum of 1 year of experience in an industry or professional setting with a focus on GDP.
• Familiarity with aseptic techniques, molecular biology, or analytical methodologies is preferred.
• Understanding of ALCOA+ principles and experience in a cGMP environment is advantageous.
• Demonstrated attention to detail and the ability to work independently with general supervision.
• Flexibility to adapt to evolving priorities and responsibilities.

• This role is based onsite in Minnesota.