Meridian Bioscience Inc. · 9 hours ago
Quality Control Analyst
North Billerica, MA
Full-time
Onsite
New Grad, Entry, Mid Level
0+ years expMeridian Bioscience Inc. is a fully integrated life science company dedicated to developing innovative diagnostic products. The Quality Control Analyst is responsible for supporting the company's Quality Policy through active participation in inspection processes, internal audits, and document management while ensuring compliance with Quality System Regulations and ISO standards.
BiotechnologyHealth CareHealth DiagnosticsLife ScienceMedical
Responsibilities
Responsible for technical inspection of incoming materials
Review qualification testing of materials, components and equipment in support of manufacturing operations
Assist in preparing for audits and documenting status of audits
Perform internal audits to ensure processes comply with company procedures, ISO 13485 and 21 CFR Part 820 requirements
Issue audit findings which identified procedural weaknesses or process deficiencies and provided recommendations for improvement
Perform root cause investigations to determine appropriate closure route for internal audit findings
Maintain CAPA progress charts to ensure CAPAs are addressed according to stated schedules and timelines
Support Quality KPI and Management review by tracking progress on QMS activities and ensuring production quality metrics are obtained and reviewed for presentation and documentation
Performed administrative review of Engineer Change Orders and input ECO documentation into the Electronic Quality Management System
Write and/or revise procedures related to quality assurance processes
Other duties as assigned
Qualification
Required
Bachelor of Science Degree with 0-2 years of experience or demonstrated success within operational area with 2-4 years of related experience required
Understand principles of Quality Management System, including requirements of Current Good Manufacturing Practice (CGMP), Good Documentation Practice (GDP), Good Laboratory Practice (GLP), Quality System Regulation (QSR), United States Department of Agriculture (USDA), and International Organization for Standardization (ISO) 13485
Excellent working knowledge of CGMP, QSR, GLP, and ISO regulations
Proficient in Microsoft Word and Excel
Practical knowledge of gauge management and qualification
Ability to conduct product or process quality investigations
Ability to interact in internal and external audits and act a role model for the QC department
Detail and process oriented
Preferred
Extensive experience with Inspection and Specification procedures
Company
Meridian Bioscience Inc.
Meridian is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic test kits, rare reagents, specialty biologicals and components.
501-1000 employees
Funding
Current Stage
Public CompanyTotal Funding
$9MKey Investors
National Institutes of Health
2022-07-07Acquired
2022-01-31Grant· $2.5M
2021-02-03Grant· $5.5M
Leadership Team
Andy Kitzmiller
Chief Executive Officer
J
Julie Smith
Chief Financial Officer
Recent News
2025-10-14
MarketScreener
2025-10-14
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