Columbia, Missouri – Quality Assurance Auditor

Reports to: Manager QA (BPSI Toronto)

Position Summary:

Responsible for performing the activities of the Quality Assurance Department USA and its team members, to ensure that the Quality Management System is efficiently and effectively implemented, maintained and improved in order to meet or exceed regulatory compliance.  To also provide regulatory guidance to the Management team, staff and Clients, to ensure proper conduct & documentation of clinical studies in accordance with regulatory requirements, in-house standard operating procedures and clinical study protocols.

This position indirectly reports to Manager QA and directly reports to the VP Global Quality Assurance.

Duties and Responsibilities:

  • Develops, directs and implements Quality Systems/Programs to ensure compliance to company standards, Industry standards and Regulatory Requirements.
  • Responsible for hosting/coordinating Client Audits and Regulatory Inspections.
  • Coordinate and provide responses to Regulatory queries, deficiency letters, and/or to inspection and Audit observations.
  • Perform audits of clinical trials for compliance with Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), study protocols, pertinent regulations and guidelines (FDA, TGA, EMA, etc.)
  • Conduct various corporate audits, including audits of equipment maintenance, training records, computer validation and vendor qualification
  • Audit pre-study documentation, in-process activities, end-of-study documentation and clinical study reports
  • Manage the SOP Process including the identification, development, approval, implementation, periodic review, revisions, controls and archival of all SOPs.
  • Review Protocols and Informed Consent Forms (ICF)
  • Coordinate GCP training.
  • Provide feedback to the QA Manager/VP regarding any Quality issues received internally and from the sponsors, visitors or Regulators.

Qualifications:

  • University degree in a scientific area, or equivalent.
  • 2-4 years QA experience, preferably including audits of Phase 1 and/or BA/BE studies.
  • Excellent working knowledge of ICH guidelines, GCP, FDA regulations and guidelines
  • Experience writing and reviewing Standard Operating Procedures (SOPs).
  • Excellent hand-eye coordination, organization, multi-tasking, communication and interpersonal skills.

Please send your resume to resumes@biopharmaservices.com