Qualtiy Systems Specialist

Qualtiy Systems Specialist (Project Management)

Quality Systems Specialist

We are currently looking to add a Quality Systems Specialist to our Quality Assurance team in St. Cloud, MN. This position supports and administers Microbiologics’ Quality Management System to ensure compliance with FDA QSR and applicable ISO standards. This role is hands‑on and detail‑oriented, focusing on Document Control, change management, and quality system processes while collaborating across departments to maintain audit‑ready, compliant systems.

At Microbiologics, we help safeguard the world's health by delivering trusted biological products and services. Our success is driven by people who win together, are driven to achieve, are brave, bold, and confident, and who care deeply about quality, compliance, and each other.

• Support and administer the Quality Management System in compliance with FDA QSR, ISO 13485, ISO 17025, and ISO 17034 requirements.
• Perform Document Control and change management activities, including electronic change orders, document processing, archiving, training coordination, and employee support.
• Support quality system processes such as CAPA verification, deviation management, supplier qualification surveys, and calibration and preventive maintenance tracking.
• Maintain accurate, organized, and audit‑ready quality records, including production, laboratory, molecular, training files, SDS, pest control records, and electronic filing systems.
• Track quality metrics and maintain communication boards; assist with audits, meetings, and special projects as assigned.
• Train and mentor employees on Document Control, change orders, cGMP, and Quality System requirements; represent the Quality Systems department as needed while prioritizing workload to meet deadlines.

Demonstrates Microbiologics’ core values by working collaboratively, taking ownership, acting with confidence and integrity, and caring about quality and compliance. Brings a growth mindset and eagerness to expand knowledge in Quality Systems and regulatory standards.

• Experience working in FDA-regulated and/or ISO-certified environments.
• Hands‑on experience with Document Control, change management, CAPA, deviations, or related quality system processes.
• Strong analytical skills with the ability to review documents and data for accuracy and compliance.
• Highly organized with strong attention to detail and the ability to manage multiple priorities.

• Proven ability to work effectively across functions such as Manufacturing, Laboratory, and Molecular teams.
• Clear written and verbal communication skills, including the ability to train and support employees on quality processes.

• Ability to troubleshoot quality system and documentation issues, support investigations, and follow through on corrective actions.
• Proactively identifies potential compliance risks or process improvements and takes initiative to address them.

• High School education or equivalent required.
• Two/Four‑year Engineering/Technical or related degree preferred.
• 5 years previous related experience and/or training preferred.
  
  Experience with ISO standards is preferred.
• Experience with Auditing, report writing, technical writing, document proofing, basic understanding of various types of equipment, both manufacturing and measurement preferred.
• Presentation, training, and measurement experience preferred.

• Meaningful work that supports global health and safety.
• Collaborative, values‑driven culture.
• Opportunities for professional growth and development.
• Competitive compensation: $24.20 - $29.05/hour.
• Comprehensive benefits package. Our benefit package includes your standard benefits such as health and dental insurance, health savings account (company funded), life insurance, short and long‑term disability, and a 401k program with a generous match to name a few. In addition, we are proud to support our team and their families by offering daycare assistance, tuition reimbursement, bonus potential.