Quality Control Analyst

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

Position Summary:

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 analyzes raw materials, in-process samples, finished products, and environmental monitoring samples while ensuring compliance with FDA, GLP, QSR, and cGMP regulations.

Key Responsibilities:

• 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.