Quality specialist Jobs in Cleveland, OH

Job Description

Position Overview

The Quality Assurance Specialist is responsible for supporting quality system processes and maintaining high standards of compliance, documentation accuracy, and process control.

Duties & Responsibilities

Key responsibilities include, but are not limited to :

• Generate, review, correct, and archive documents supporting Good Manufacturing Practice (GMP) production activities.
• Conduct internal and external audits as assigned.
• Review and release raw materials, intermediate products, and finished goods; assist with incoming material and container inspections.
• Review and approve OOS (Out of Specification), deviations, nonconformances, and investigations.
• Coordinate CAPA, OOS, deviation, nonconformance, and investigation activities.
• Ensure compliance with current SOPs and quality system requirements.
• Assist with investigations and support resolution of product quality issues to enhance operational efficiency.
• Create, revise, and approve standard operating procedures and work instructions.
• Review and approve SOPs, protocols, and reports as required.
• Coordinate and / or deliver GMP and SOP training.
• Generate, track, and publish quality system metrics to support continuous improvement initiatives.
• Scan and archive GMP records and documentation.
• Support Quality Control Laboratory functions such as calibration and product release activities.
• Provide assistance to Environmental, Health, and Safety programs as needed.
• Perform other duties as assigned by the Quality Assurance Manager.

General Requirements

Skills, Qualifications & Experience

Opening Doors to Incredible Opportunities :

For over two decades, Capstone has been working with elite organizations from Fortune 500s to start-ups in some of the most competitive market sectors. Because of our deep connections, we're able to match you with the most relevant and prestigious career opportunities available - whether you're an executive or manager, we'll help you reach your professional goals.

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Equal Opportunity Employer :

Capstone provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. We celebrate diversity and are committed to creating an inclusive environment for all employees. Capstone will provide reasonable accommodations for people with disabilities in all parts of the hiring and employment process.