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Quality Control Analyst Job in Cincinnati, Ohio US

Quality Control Analyst

Meridian Bioscience, Inc. - Cincinnati, OH

Posted: 8/8/2022 - Expires: 11/6/2022

Job ID: 245494487

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Job Description

Quality Control Analyst


Job Locations

US-OH-Cincinnati



Company

Meridian Bioscience, Inc.


Department

Quality Control


# of Openings

1


About Meridian




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




Purpose:

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.

 

Relationships:

Key Stakeholders

Works as part of an interdisciplinary team of Quality Control professionals. Interaction normally requires the ability to establish strong working relationships with various departments to facilitate collaboration and cooperation.

 

Direct Management:

Reports To: Manager or Director level professional

Supervision/Managerial: Individual Contributor

 

Responsibilities May Include:

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.


Key Duties




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.


Qualifications




Knowledge, Skills and Abilities:

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.

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.

Detail and process oriented.

 

Education and Experience:

Bachelor of Science Degree or equivalent experience required

At least 1-year experience in a FDA regulated environment required.

 

Requirements

Travel

Not anticipated. However, must be able to travel by car/air to other MBI locations and/or supplier locations as needed.

Physical

N/A

Other

Ability to walk up and down several flights of stairs throughout the workday in a multi-location facility

Must be able to wear personal protective equipment (latex or nitrile gloves, safety glasses/face shields, lab coat, etc.).

Must be able to adhere to applicable bio-safety practices when on the manufacturing floor.

Ability to work on a PC including repetitive use of a keyboard and mouse for long periods throughout the course of the workday.

Must be able to analyze, concentrate, and solve complex issues throughout the work day

We are proud to be an EEO/AA employer Minority/Female/Disability/Veteran. We maintain a drug-free workplace and perform pre-employment substance abuse testing.

Job Summary

Employment Type:
Full Time Employee
Job type:
Federal Contractor
Skill Based Partner:
No
Education Level:
Bachelor's degree
Work Days:
Mon, Tue, Wed, Thu, Fri
Job Reference Code
68761692
Salary
N/A
Licenses / Certifications:
N/A
Display Recommended WorkKeys®Recommended WorkKeys®:
N/A