Quality Assurance Specialist
Job ID: 291292
Location: St. Louis, Missouri, United States
Job Type: Full-time
About Us
Work Your Magic with us! Start your next chapter and join MilliporeSigma.
We are innovators in Healthcare, Life Science, and Electronics. Across the globe, our teams explore, break barriers, and enrich lives with solutions that matter. If you’re ready to imagine the unimaginable, we want you on our team.
Note: This role does not offer sponsorship for work authorization. Applicants must be eligible to work in the US.
Your Role
As a Quality Assurance Specialist, you will provide compliance oversight for the St. Louis ISCO MilliporeSigma Quality Management System (QMS), ensuring alignment with regulatory requirements and company standards. You will drive continuous improvement of quality systems and promote a culture of compliance and quality excellence.
Key Responsibilities
Improve and maintain quality systems in ISO production environments, ensuring compliance with Life Science and site policies.
Manage the electronic documentation system, including writing, reviewing, and approving controlled documents (SOPs, Specifications, Master Manufacturing & Packaging Procedures).
Oversee training management, metric reporting, and electronic training platform administration.
Conduct or lead internal audits to ensure compliance with policies.
Support KPIs by ensuring timely closure of CAPAs, Deviations, Complaints, and Change Controls.
Investigate customer complaints and contribute to Root Cause Analysis and Effectiveness Checks.
Communicate across departments to support overall quality objectives.
Deliver Quality System Training relevant to various job functions.
Physical Requirements
Environment: 70–100% office-based; 10–30% on-the-floor QA activities/observation.
Mobility: Ability to give site tours, including use of stairs.
Who You Are
Minimum Qualifications
Option 1: Bachelor’s Degree in Life Science (Chemistry, Pharmacy, etc.) or Engineering (Chemical, Process, etc.) + 5+ years experience in the Life Science industry.
Option 2: Bachelor’s Degree in any discipline + 5+ years in a Quality Assurance role.
Option 3: Master’s Degree in Life Science (Chemistry, Pharmacy, etc.) or Engineering (Chemical, Process, etc.) + 2+ years experience in the Life Science industry.
Preferred Qualifications
2+ years’ experience with ISO 9001, ISO 13485, and regulatory compliance (FDA, USDA, EXCiPACT, ICH, EDQM, IVDR).
Prior experience in a controlled/regulated environment with biologic-derived materials.
Strong computer skills (MS Word, Excel, Access, Project, PowerPoint) and ability to use enterprise software (SAP, Trackwise, etc.).
Strong communication and customer service skills (verbal & written).
Technical writing skills for documentation and reports.
Ability to manage multiple priorities, solve problems effectively, and work independently.
Strong time management and negotiation skills.
Compensation & Benefits
Pay Range: $66,800 – $109,300 annually
Actual pay depends on location, experience, education, and skills
May be eligible for performance-based bonuses
Benefits include:
Health insurance
Paid time off (PTO)
Retirement contributions
Additional perks and programs
What We Offer
At MilliporeSigma, we celebrate diversity and inclusion, drawing strength from a broad mix of perspectives and experiences. We empower you to grow at your own pace while working toward innovations that improve millions of lives.
Apply Now
Join a team committed to sparking discovery and elevating humanity.
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