Microbiology Tech II Job Saint Paul area,Minnesota USA,Quality Assurance

Job Title: Microbiology Tech II-Quality Inspector role
Work Location: St. Paul, MN-100 % onsite (New Brighton location)
Work Hours: 7:00 AM 3:30 PM
- Workdays: Monday-Friday
Duration: 6 Months with possible extension

Note: Selected candidate will start ASAP after screenings have cleared. Site is looking to start someone urgently

Job Description:

Preference will be given to those candidates who do not have to relocate to accept the position, and who are eligible to start work within two weeks of a job offer, thank you.
Site has recently adjusted the main purpose of this role; however, please note that it may evolve further based on the needs of the site.
Ideally, we are looking for someone who is flexible and brings a broad set of relevant skills, as outlined below.
Will be utilizing skill sets within both Microbiology Technician and Quality Inspection.

Position Summary:

This hybrid role combines responsibilities in both Quality Inspection and Microbiology Environmental Monitoring to support site quality, compliance, and manufacturing operations.
The ideal candidate is flexible, adaptable, and capable of performing a broad range of quality assurance and microbiological testing activities.
Responsibilities include inspection and testing of materials and products, as well as environmental monitoring of cleanroom environments using aseptic techniques and laboratory documentation systems.

Ideal Candidate Profile:

The successful candidate will be a versatile quality professional with a combination of inspection and microbiology skills, capable of supporting both product quality and cleanroom environmental monitoring activities while maintaining compliance with regulatory, quality, and documentation requirements.

Key Responsibilities:
Quality Inspection:

Perform visual, dimensional, and functional inspections of purchased materials, components, and finished products according to established procedures.
Conduct testing and inspections to verify compliance with quality specifications and regulatory requirements.
Accurately record inspection and test results in applicable systems and documentation.
Identify and document non-conforming materials within the Non-Conforming Material Review (NCMR) system.
Recommend improvements to quality policies, procedures, and inspection processes.
Ensure compliance with FDA regulations, company quality standards, and applicable regulatory requirements.
Support Quality Management System (QMS), Environmental Management System (EMS), and other regulatory initiatives.
Collaborate effectively with cross-functional teams, suppliers, customers, and contractors to maintain quality objectives.

Microbiology & Environmental Monitoring:

Perform environmental monitoring activities within cleanroom environments using aseptic handling techniques.
Conduct viable air sampling, viable surface sampling, and non-viable particulate monitoring.
Perform compressed dry air sampling (preferred experience).
Utilize Lab Vantage Laboratory Information Management System (LIMS) to document testing and monitoring activities.
Adhere to Good Documentation Practices (GDP) and maintain accurate laboratory records.
Follow established microbiology protocols, contamination control procedures, and cleanroom requirements.
Support microbiological investigations and corrective actions as needed.

Qualifications & Skills

Experience in Quality Inspection, Microbiology, Environmental Monitoring, or a related regulated manufacturing environment.
Knowledge of aseptic techniques and cleanroom practices.
Familiarity with environmental monitoring methods, including viable and non-viable sampling.
Strong understanding of quality systems, inspection processes, and regulatory compliance requirements.
Experience with Laboratory Information Management Systems (LIMS), preferably Lab Vantage.
Excellent documentation skills with strict adherence to Good Documentation Practices (GDP).
Strong computer proficiency and ability to learn site-specific software systems.
Detail-oriented with strong organizational and problem-solving abilities.
Effective communication and collaboration skills.
Ability to adapt to changing site priorities and business needs.

Education Requirements:

High School Diploma / GED or an equivalent combination of education and work experience
Two- or four-year degree in microbiology/biology or minimum of two-year science curriculum desired.