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Clinical Laboratory Quality Assurance Specialist
  • Location: Chicago, IL
  • Type: Direct Hire
  • Job #15635

Lighthouse Lab Services is excited to represent a laboratory in Chicago that is looking for a Quality Assurance Specialist to add to their growing team! 

Position Overview:  

  • The primary responsibility of this position is maintaining records of training and competency, conducting internal quality process audits, data, and document review, archiving and record management, and preparing Standard Operating Procedures.   

The Role You'll Play:  

  • Assists in administering and maintaining the electronic quality management systems 

  • Coordinates documentation and archival of training and competency records 

  • Assists in coordinating vendor audits, scheduling and hosting external audits 

  • Assists with writing, revising, and controlling SOPs to comply with regulatory requirements 

  • Assists with review and approval of procedural deviations and change management. 

  • Helps to manage quality management and documentation tool 

  • Conducts process audits for compliance with internal SOPs and regulatory standards 

  • Contributes to or writes audit reports 

  • Audits analytical reports for compliance with internal SOPs and regulatory standards 

  • Assists in managing non-conforming events and ensuring that non-conforming event documentation complies with internal SOPs 

  • Assists with regulatory and safety training for staff and maintaining training records 

  • Acts as an archivist for the company and maintains physical and electronic records 

  • Assists in implementing and managing the continuous laboratory improvement program 

  • Reviews documentation for equipment acceptance, material acceptance, and assay validations. 

  • Employee may be asked to perform additional tasks as required. 

Candidate Profile: 

  • Bachelor's degree in related field is required 

  • Minimum of 3 years of industry experience in a CLIA Laboratory 

  • Knowledge of CLIA and CAP regulatory standards.  Additional GCLP experience preferred 

  • Demonstrated history of working with strong attention to detail 

  • Proven organizational and time management skills with ability to multi-task 

  • Proven ability to work in a team atmosphere 

  • Understanding of laboratory testing processes and methods 

  • Completion of CAP team member training is a plus 

About Us: 

At Lighthouse Lab Services, we offer solutions to help start, grow, and run clinical laboratories. Our recruiting team has over 18 years of proven success placing job seekers in positions ranging from entry-level Medical Technologists to seasoned Laboratory Directors. We recruit nationwide, for permanent and travel positions with clients ranging from small hospitals to large reference laboratories. 

It is the policy of Lighthouse Lab Services to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state, or local law. In addition, Lighthouse Lab Services will provide reasonable accommodations for qualified individuals with disabilities. 

Lighthouse Lab Services | 800-838-0602 | lighthouselabservices.com 

#DS # 15635

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