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Quality Assurance Specialist

Cleveland, OH 44101

Posted: 12/10/2025 Job Category: Food and Science Job Number: 832360 Pay Rate:

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

  • Bachelor’s degree in a scientific discipline or equivalent experience.
     

  • Minimum of 2 years' experience in a cGMP/FDA-regulated environment (preferred) and working with ISO 9001 within Quality Assurance or Compliance functions.
     

  • Proficiency in Microsoft Office, especially Excel.
     

 
Skills, Qualifications & Experience

  • Strong knowledge of ISO 9001:2015, ISO 14001:2015, cGMP, CFR 210/211, FDA requirements
     

  • Experience in a manufacturing environment (chemical manufacturing or processing preferred).
     

  • Familiarity with Statistical Process Control (SPC) and relevant software tools.
     

  • Ability to evaluate and quantify cost of quality using data-driven KPIs.
     

  • Strong project management, time management, and conflict-resolution skills


 

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Equal Opportunity Employer:
TalentLaunch 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. TalentLaunch will provide reasonable accommodations for people with disabilities in all parts of the hiring and employment process.

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About Cleveland, OH

Unlock your potential in Cleveland, Ohio! Nestled on the shores of Lake Erie, Cleveland offers job seekers a vibrant mix of career opportunities and a welcoming community to grow in. Known as "The Rock and Roll Capital of the World," Cleveland boasts a rich cultural scene with landmarks like the Rock and Roll Hall of Fame, Playhouse Square, and the Cleveland Museum of Art. Indulge in local delicacies like pierogies and explore the scenic Metroparks for outdoor adventures. Cheer for the Cleveland Cavaliers at the Quicken Loans Arena or catch a show at the historic West Side Market. Find your dream job in Cleveland and be part of this city's irresistible charm and endless possibilities!