Quality Specialist

Company: Cleveland Diagnostics Inc.
Location: Cleveland
Posted on: May 27, 2023

Job Description:

Quality Specialist
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Our team is growing and we currently have an immediate opening for a Quality Specialist.
Job Overview:Quality Specialist is responsible for the supplier management program, formal review of product batch records, change control system, and performing internal audits as needed. Must also perform other duties related to the company's quality system when required. Must have high attention to details and be able to analyze/solve complex problems and make decisions necessary to keep productivity high and the company functioning smoothly.
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Essential Duties and Responsibilities:

Responsible for supplier management program including supplier surveys, supplier corrective action requests (SCARs), scorecards, etc.
Perform quality review of batch records and associated documents resulting from manufacturing of company products
Manage overall change control system for evaluating and implementing changes to products, raw materials, equipment, etc.
Perform internal audits of quality systems to ensure compliance

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Education and/or Work Experience Requirements:

Solid knowledge and understanding of quality system concepts
> 3 years of experience in a Quality Control or Quality Assurance role is preferred
Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers and employees.
Excellent computer proficiency (MS Office - Word, Excel, PowerPoint, and Outlook)
Ability to work independently and to carry out assignments to completion within parameters of instructions given, prescribed routines, and standard accepted practices
Bachelor's degree in a scientific discipline is required
Good Manufacturing Practices (GMP) is preferred
Good Documentation Practices (GDP) is preferred



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Physical Requirements/ Working Conditions/Equipment Used:

Ability to safely and successfully perform the essential job functions consistent with the ADA, FMLA and other federal, state and local standards, including meeting qualitative and/or quantitative productivity standards.
Ability to maintain regular, punctual attendance consistent with the ADA, FMLA and other federal, state and local standards
Exertion: Light
Physical Effort: Position may require walking, standing, climbing stairs, bending, stooping, lifting
Must be able to complete tasks in a lab/office environment
Desk position sitting and operating computer for the majority of the time
The ability to wear personal protective (PPE) gear correctly during the workday
Domestic/International Travel: NO


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COVID-19 considerations:
Full COVID-19 vaccination is required.
PI217767159

Keywords: Cleveland Diagnostics Inc., Cleveland , Quality Specialist, Other , Cleveland, Ohio