Quality Control Analyst

Meridian Bioscience, Inc.•Newtown, OH

53d

About The Position

Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity that are redefining the possibilities of life from discovery to diagnosis. We are looking for talented and passionate individuals that help drive our vision. Our innovative culture will allow interested candidates to discover and create, through collaboration, cutting edge solutions to tough problems. Job Summary Responsible for supporting Meridian’s Quality Policy and operating procedures through taking an active role in the qualification of acquired specimens for use in lab production, quality control, technical support, and validations/investigations. Utilize instruments and preparing standard and stock solutions; calibration and value assignments of sensor lots, recording and analyzing test data, maintaining/calibrating/validating lab instruments and equipment; shipping manufactured reagents, order QC supplies. Troubleshoot customer complaints, perform investigative and development studies, and perform related laboratory work A heavy emphasis on documentation and process controls in compliance with current Quality System Regulations and ISO standards is required.

Requirements

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.
Detail and process oriented.

Nice To Haves

Extensive experience with Out of Specification procedures is preferred.
Ability to interact in internal and external audits and act a role model for the QC department.

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.