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Microbiologics · 11 hours ago

Qualtiy Systems Specialist

St Cloud, MN

Full-time

Onsite

Mid, Senior Level

$24.20/hr - $29.05/hr

5+ years exp

Microbiologics is dedicated to safeguarding global health through trusted biological products and services. They are seeking a Quality Systems Specialist to support and administer their Quality Management System ensuring compliance with FDA QSR and ISO standards, while focusing on document control and quality system processes.

Biotechnology

H1B Sponsor Likely

Responsibilities

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

Qualification

Quality Management SystemFDA QSR complianceISO standardsDocument ControlCAPAAnalytical skillsTraining experienceCollaborationCommunication skillsProblem-solving

Required

High School education or equivalent

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

Preferred

Two/Four-year Engineering/Technical or related degree

5 years previous related experience and/or training

Experience with ISO standards

Experience with Auditing, report writing, technical writing, document proofing, basic understanding of various types of equipment, both manufacturing and measurement

Presentation, training, and measurement experience

Benefits

Health and dental insurance

Health savings account (company funded)

Life insurance

Short and long-term disability

401k program with a generous match

Daycare assistance

Tuition reimbursement

Bonus potential

Company

Microbiologics

Microbiologics is the world's leading provider of biological references materials for quality control testing.

Founded in 1971

Saint Cloud, Minnesota, USA

201-500 employees

http://www.microbiologics.com/

H1B Sponsorship

Microbiologics has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (3)

2024 (1)

2023 (3)

2022 (1)

2021 (2)

2020 (1)