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Laboratory Quality Assurance (QA) Man...
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Manager Quality Assurance Cincinnati, OH Quality Assurance, Cincinnati, OH

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Laboratory Quality Assurance (QA) Manager

Medpace Cincinnati, OH (Onsite) Full-Time
Responsibilities


  • Manage Internal and External Laboratory related Audits according to current applicable Regulations;

  • Coordinate, conduct and track company-wide Regulatory training and Quality Event Management;

  • Management and oversight of departmental Standard Operating Procedures, forms and templates;

  • Host Audits/Inspections by Sponsors and Regulatory Inspectors in a Clinical Lab setting;

  • Conduct vendor audits;

  • Coordinating, conducting, and tracking Regulatory Training (GLP and ICH/GCP) on a company wide basis;

  • Supervise QA Lab Auditors and Associates;

  • Assisting QA leadership with departmental overview and development of QA Auditors;

  • Developing training materials and applicable tests and guides.



Qualifications


  • Bachelor’s degree in Life Sciences or a related field;

  • 3 - 5 years of experience in a lab setting in a related industry required;

  • Knowledge and application of GCP and GLP is required;

  • Past supervisory experience is preferred;

  • Experience in conducting audits of vendors;

  • Experience in hosting Regulatory Authorities and interacting with Sponsor/client representatives;

  • Independent thinking and planning ability;

  • Excellent written and verbal communication skills.


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Recommended Skills

  • Communication
  • Event Management
  • Leadership
  • Standard Operating Procedure
  • Coordinating
  • Auditing

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Job ID: j4li61e

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