Quality Control Analyst II

Overview

We are seeking a motivated and detail-oriented Quality Control Analyst I to join a growing team onsite in Minnesota. This is an exciting opportunity for someone looking to build their career within Quality Control and biologics manufacturing in a GMP-regulated environment.

The successful candidate will support analytical testing activities across raw materials, intermediates, and drug substance/products to ensure compliance with cGMP and regulatory standards.

This role is ideal for an individual with a foundational understanding of biologic therapeutics who is eager to develop hands-on experience within Quality Control.

Experience with cell-based assays and/or PCR-based analyses is highly desirable.

Responsibilities

• Perform routine analytical testing for GMP manufacturing and product quality assessment
• Execute assays across molecular, biochemical, and cell-based systems
• Support testing activities related to in-process and post-production product quality
• Maintain laboratory equipment and support routine reagent management
• Perform accurate sample tracking and documentation in line with cGMP and Good Documentation Practices (GDP)
• Support release assay validation and product stability activities
• Participate in laboratory housekeeping, calibration, and quality initiatives
• Maintain high standards of laboratory safety, compliance, and data integrity
• Work collaboratively within the QC team while learning systems, methods, and compliance expectations
• Support additional laboratory and operational activities as required

Requirements

• Bachelor’s degree in a science-related field
• Minimum of 1 year of experience in an industry or professional setting incorporating GDP
• Familiarity with aseptic technique, molecular biology, or analytical methods preferred
• Understanding of ALCOA+ principles and familiarity with cGMP environments preferred
• Strong attention to detail and ability to work independently under general direction
• Flexibility to adapt to changing priorities and responsibilities

Additional Information

• Onsite role based in Minnesota