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Quality Assurance Auditor

Chicago, IL

Posted: 06/05/2019 Employment Type: Contract Job Category: Clinical: Quality Job Number: 2367

The Quality Assurance Auditor is responsible for planning and conducting good clinical practice (GCP) audits, supporting vendor management qualification activities including GxP audits and risk assessment practices, supporting compliance and quality initiatives, and being a champion and promulgating a quality culture.

Primary Responsibilities:
  • Schedules, plans and conducts internal process audits according to the Internal Audit Plan and applicable SOP or Work Instruction, including the completion of an audit report. Tracks and manages any post audit activities and follows corrective or preventative actions to closure.
  • Supports Supplier Evaluation and Monitoring through timely evaluation activities, to include the planning and conducting of vendor qualification and re-qualification audits, review of vendor evaluation questionnaires and ongoing monitoring activities.
  • Assists with the coordination of regulatory agency inspections.
  • Participates in ongoing audit and inspection readiness activities, including training compliance oversight, SOP and corporate policy compliance, and ongoing quality support to project teams
  • Identifies and mitigates non-compliances, participating in or conducting effective Root Cause Analysis and development of corrective and preventative actions.
  • Collaborates and serves as a Quality Point of Contact for departmental and cross-functional teams to provide quality support to projects and initiatives.
  • May author initial and revised Quality controlled documents, working with cross functional and departmental leads to ensure consistent and applicable processes.
  • May author and/or provide training on compliance and quality topics and processes.
  • Able to travel up to 20%.

  • BA/BS degree or equivalent
  • 3-4 years of quality assurance and GCP auditing experience in the clinical research or healthcare sector
  • Excellent verbal and written communication skills
  • High level of attention to detail
  • Strong professional and interpersonal skills
  • In depth knowledge of clinical research industry, auditing best practices, and FDA regulations and ICH  GCP guidance
  • Ability to work independently

Lisa Madden
EVP, Clinical Staffing

Lisa is an inspiring leader and mentor, driven by an inherent desire to help others and make a difference. An advocate for growth and professional development, Lisa brings 18 years of recruiting and business development experience to The Steely Group, and as Executive Vice President of Clinical Staffing, she oversees the direction and strategy of the Steely recruiting team.

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