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Reference Number:
USA_3135
Job Description:
Duties related to audit program include: internal/clinical trials/supplier audit function planning, developing audit schedules and plans, performing and documenting audits and managing all related following up activities.
The Staff auditor will act as a mentor to auditors/lead auditors and clinical research associates (CRA), supporting the development, training and supervision of these employees.
Responsible for implementing and maintaining the effectiveness of the Quality System
Leads in internal and external audit program in accordance with Corporate and Divisional standards in order to assure that Quality Systems and controls (including performance metrics and analysis) are appropriate and maintained. Such standards include FDA QSR, ICH, GCP, ISO 13485 and 14971, PAL, CMDR, MDD and IVDD.
Ensures that process and procedures related to Internal Auditing are followed and adhered to.
Conducts Clinical trial audits and performs any related follow-up activities.
Conducts Supplier audits and performs any related follow-up activities
Facilitates external audits as performed by Corporate or Regulatory agencies
Identifies and generates process and program metrics in collaboration with site and divisional requirements
Able to deputize for Audit Manager, as requested. and provide support in areas of staff supervision, training clinical trial staff, as necessary.
-Must demonstrate excellent interpersonal skills when dealing with internal and external customers under stressful circumstances
Bachelors Degree in Medical Technology, Chemistry, Biology, or another scientific discipline.
Certified Quality Auditor (ASQ) or Certified Lead Auditor (RAB recognized organization). Clinical Trial certification (CCRA or CCRC preferred) or experience of Clinical Trial auditing/operational experience is required.
Extensive knowledge of regulations and standards affecting IVDs, Biologics and Clinical trials (FDA QSR, ICH, GCP, ISO 13485 and 14971, PAL, CMDR, MDD and IVDD)
5-8 years QA and/or RA experience in a medical device quality system including extensive experience conducting internal and external audits according to the guidelines described in ISO 19011
3-5 years experience of Clinical Trial auditing/operational environment
3 years in management or lead auditing experience
Excellent writing, communication, objectivity and interpersonal skills, especially in stressful circumstances
Strong team building and decision making skills
Strong ability to identify, analyze, and report opportunities for improvements and lead to successful implementation of solutions
Proficiency with software applications such as MS Word, Excel, Access, Visio, IBM Lotus Notes and be able to maintain simple databases for the purpose of tracking/trending audit findings
Experience with training and mentoring of auditors, CRAs
Experience Level:
5+ Years
Requirements:
Responsible for the implementation of audits required for compliance with Regulatory standards and leads improvement activities within the Quality System department.
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