Quality Assurance Auditor

Ann Arbor, MI

Contract

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OVERVIEW

At Advanced Clinical, we’re excited to share with you a great opportunity at growing organization committed to clinical excellence for the position of Quality Assurance Auditor. The Quality Assurance Auditor will be responsible for the development, implementation, and maintenance of all Quality Management Systems and activities. As they support the Clinical Development programs and studies, their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity!

RESPONSIBILITIES

  • Ensure GCP compliance for all global Clinical Development studies (Phases I - III)
  • Develop and maintain schedules for audits of Clinical Research Organizations (CRO), clinical sites, and internal Clinical Development systems
  • Lead and report all internal and external audits
  • Develop, implement, and maintain all Quality Management Systems and activities in support of Clinical Development programs and studies
  • Oversight and approval of SOPs and operational documents related to Clinical Development
  • Develop and maintain Quality Agreements with current Clinical Development CROs
  • Conduct QA document reviews for submission to regulatory agencies
  • Present quality metrics and trends to executive management at periodic Quality Review meetings
  • Collaborate with other Quality and Training functions

EXPERIENCE

  • Minimum 5-10 years experience in a quality unit as a GCP Auditor/Senior Quality role
  • Minimum 5 years supervisory/management experience
  • Knowledge of GCP/ICH regulations for the pharmaceutical/biotech industry
  • Experience with Electronic Quality Management Systems (SharePoint)

EDUCATION

  • Bachelor’s Degree required, preferably in health/science or related field
  • Master’s Degree preferred

To be a best-fit your strengths must include

  • Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology. 
  • Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines. 
  • Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure. 
  • Problem-Solvers.  As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
  • Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.   
  • Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.  

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.

Regarding your application

Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

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