Microbiology Tech II / Quality Inspector

Job Title: Microbiology Tech II / Quality Inspector (Hybrid Role)

Location: St. Paul, MN (New Brighton)
Duration: 6 months'
Work Schedule: Monday Friday | 7:00 AM 3:30 PM

Position Overview

We are seeking a Microbiology Tech II / Quality Inspector to support both Quality Inspection and Microbiology Environmental Monitoring activities in a regulated manufacturing environment. This hybrid role requires a flexible, detail-oriented professional who can perform product inspections while also supporting cleanroom environmental monitoring and microbiology testing. The ideal candidate will ensure compliance with FDA regulations, quality standards, and documentation requirements while contributing to manufacturing and quality operations.

Key Responsibilities

Quality Inspection

• Perform visual, dimensional, and functional inspections of incoming materials, components, and finished products.
• Conduct quality testing to ensure compliance with specifications and regulatory requirements.
• Record inspection and testing results accurately in applicable systems.
• Identify, document, and process non-conforming materials using the NCMR system.
• Recommend improvements to inspection methods and quality procedures.
• Ensure compliance with FDA regulations, company quality standards, and internal procedures.
• Support Quality Management System (QMS), Environmental Management System (EMS), and continuous improvement initiatives.
• Collaborate with suppliers, manufacturing teams, contractors, and cross-functional departments.

Microbiology & Environmental Monitoring

• Perform environmental monitoring activities in cleanroom environments using aseptic techniques.
• Conduct viable air sampling, surface sampling, and non-viable particulate monitoring.
• Perform compressed dry air sampling (preferred).
• Document laboratory activities using LabVantage LIMS.
• Maintain accurate records following Good Documentation Practices (GDP).
• Follow microbiology protocols, contamination control procedures, and cleanroom requirements.
• Assist with microbiological investigations and corrective actions.

Required Qualifications

• Experience in Quality Inspection, Microbiology, Environmental Monitoring, or a regulated manufacturing environment.
• Knowledge of aseptic techniques and cleanroom operations.
• Experience with environmental monitoring methods, including viable and non-viable sampling.
• Understanding of quality systems, inspection processes, and regulatory compliance.
• Experience using LIMS (LabVantage preferred).
• Strong knowledge of Good Documentation Practices (GDP).
• Excellent documentation, organizational, and problem-solving skills.
• Strong computer proficiency and ability to learn new software systems.
• Excellent communication and teamwork skills.
• Ability to adapt to changing priorities and business needs.

Preferred Qualifications

• Experience performing compressed dry air sampling.
• Previous experience in medical device, pharmaceutical, biotechnology, or other regulated manufacturing industries.
• Experience supporting cleanroom manufacturing operations.

Education Requirements

• High School Diploma or GED (or equivalent combination of education and experience).
• Associate's or Bachelor's degree in Microbiology, Biology, or related Life Science preferred.
• Minimum of two years of science coursework is desired.