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Meridian Bioscience Inc. · 2 days ago

Quality Control Analyst

Cincinnati, OH

Full-time

Onsite

New Grad, Entry Level

Meridian Bioscience Inc. is a fully integrated life science company dedicated to developing innovative diagnostic products. The Quality Control Analyst will support the company's Quality Policy by conducting qualification testing of specimens and reagents, troubleshooting customer complaints, and maintaining documentation in compliance with regulatory standards.

BiotechnologyHealth CareHealth DiagnosticsLife ScienceMedical

Responsibilities

Responsible for technical work of testing specimens, reagents, sensors and equipment to specifications and standards

Perform qualification testing of materials, reagents, sensors, and equipment in support of manufacturing operations

Conduct tests of biomedical electrodes, and sensors which involve setting up testing instruments and systems; utilizing chart readings; measuring standards; and interpreting test data

Analyze test data on all conducted tests and make necessary calculations to obtain final test results

Prepare and maintain complete records on all tests

Troubleshoot customer complaints which include testing product to verify complaint and analyzing test data to determine extent of action or recommend resolution of problem/complaint

Perform investigative studies into Production problems and perform development studies related to new product identification and documentation

Fulfill submitted specimen requests

Input specimen data into the specimen database

Maintain and evaluate specimen inventory levels

Write and/or revise specimen database procedures

Write and/or revise assay related procedures

Perform final testing of Proficiency and Control samples or arrange for outside evaluation

Write and/or revise procedures related to proficiency samples

Other duties as assigned

Qualification

Quality Management SystemFDA-regulated environmentELISA proficiencyMicropipettingAnalytical balancesHPLCLaboratory PracticeProcess orientedMicrosoft WordMicrosoft ExcelDetail oriented

Required

Bachelor of Science Degree or equivalent experience required

Experience in an FDA-regulated manufacturing, or laboratory environment is desirable

Working knowledge/hands-on experience with at least some of the following: micropipetting, microscopes, ELISA plate readers, laminar flow hoods, PCR hoods, analytical balances, centrifuges, pH meters, aseptic technique, IVD test kits

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

Demonstrates proficiency with ELISA, SDS-PAGE (Coomassie Stain, Silver Stain, Western Blotting), endotoxin analysis, immunodiffusion, HPLC, pH, and bioburden analysis

Experience in authoring and executing test method validations

Excellent working knowledge of CGMP, QSR, GLP, and ISO regulations

Proficient in Microsoft Word and Excel

Practical knowledge of control and standards management and qualification

Ability to conduct product or process 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 Out of 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.

Founded in 1977