Quality Control Analyst I

Position Title: Quality Control Analyst

Work Location: St. Paul, MN (Onsite)

Assignment Duration: 12 Months

Work Schedule: Monday-Friday, 6:00 AM - 3:30 PM

Work Arrangement: Onsite

We are seeking a detail-oriented Quality Control Analyst to perform biological, chemical, and physical testing of medical device products throughout various stages of the manufacturing process.

This role is responsible for analyzing raw materials, in-process samples, finished products, and environmental monitoring samples while ensuring compliance with FDA, GLP, QSR, and cGMP regulations.

• Perform laboratory testing on raw materials, in-process samples, finished products, and environmental monitoring samples.
• Conduct biological, chemical, and physical analyses using laboratory instrumentation and analytical equipment.
• Utilize laboratory computer systems, including LIMS, to accurately document and maintain test results.
• Execute analytical assays and testing protocols while ensuring data integrity and accuracy.
• Complete routine and special project testing within established timelines.
• Prepare and maintain laboratory documentation, including deviations, investigations, and exception reports.
• Ensure compliance with SOPs, FDA regulations, GLP, QSR, and cGMP requirements.
• Assist in laboratory audits, manufacturing audits, and continuous quality improvement initiatives.
• Review, update, and maintain standard operating procedures (SOPs).
• Perform equipment maintenance, calibration, and troubleshooting as needed.
• Collaborate with cross-functional teams to improve processes, efficiency, and product quality.

• Bachelor's Degree in Chemistry, Biochemistry, Biology, Microbiology, Biological Sciences, or a related Life Science discipline.
• 0-2 years of laboratory, quality control, analytical chemistry, microbiology, medical device, pharmaceutical, or biotech experience.
• Understanding of GMP/cGMP, GLP, FDA, and quality system regulations.
• Experience working with laboratory instrumentation and analytical testing methods.
• Familiarity with LIMS or other laboratory documentation systems is preferred.
• Strong documentation, data analysis, and problem-solving skills.
• Ability to manage multiple priorities in a fast-paced laboratory environment.
• Strong verbal and written communication skills.
• Proficiency with Microsoft Office and computer-based systems.