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Clinical Quality Consultant

Company: Aerotek
Location: Rochester
Posted on: January 15, 2022

Job Description:

Job Title: Clinical Quality Consultant **FULLY REMOTE**Objectives:Support the Clinical Quality Assurance function within Research and Development Operations ensuring clinical trials supporting pharmaceutical and medical device registrations are conducted in compliance with all applicable regulations. Develop and sustain robust quality systems. Responsibilities:

  • Establish and maintain effective strategies, systems and procedures, ensuring compliance with applicable GCP standards
  • Author/review summary reports, memos and standard operating procedures
  • Support internal and regulatory inspections.
  • Support audited groups in developing effective, risk based corrective actions.
  • Partner with key customer groups in clinical Operations to develop and meet quality objectives.
  • Evaluate and improve existing processes with limited guidance
  • Maintain on the job knowledge and skills by participating in applicable trainingKey Relationships:
    • Internal and external customers / sitesQualifications:
      • Minimum BS/BA in related field
      • Working knowledge of GCP regulations/ guidelines (ICH, US FDA, ISO)
      • Clinical Research Certification strongly desired
      • Strong computer skills
      • Excellent communication (verbal and written) skills and ability to work effectively on teams.
      • Excellent organizational skills.
      • Minimum 5 years' experience in related healthcare, medical device, or pharmaceutical industry About Actalent:Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. Were supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Aerotek, Rochester , Clinical Quality Consultant, Professions , Rochester, New York

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