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Clinical (Gcp) Quality Assurance Specialist

Company

a pharmaceutical company located in the Menlo Park, CA area
Address Menlo Park, CA, United States
Employment type FULL_TIME
Salary
Category Biotechnology Research,Pharmaceutical Manufacturing
Expires 2023-07-29
Posted at 10 months ago
Job Description

Clinical (GCP) Quality Assurance Specialist


RESPONSIBILITIES

  • Supporting GMP, GLP and PV inspections
  • Mentoring / coaching junior QA team members upon request or as an assigned supervisor
  • Providing cross training development opportunities to QA team members
  • Leading / managing GCP audits, including clinical investigative site audits, clinical vendor audits, clinical department internal audits, TMF audits, and applicable study document audits, including CSRs
  • Leading clinical non-compliance event investigations and CAPA implementation
  • Managing and supporting inspection readiness activities for GCP
  • Performing quality metric analysis for clinical QA including study quality event trends from clinical process deviations / CAPAs to include review of protocol deviations, safety, and other clinical data
  • Maintain a contemporary knowledge of current agency and industry trends, standards, and methodologies as related to GCPs.
  • Leading continuous improvement of the Clinical Quality Management Systems (CQMS) and processes, including creation and revision of SOPs for GCP compliance and excellence.
  • Serving as a QA representative and support clinical study teams to provide compliance advice during team meetings or other method of communications.
  • Reviewing and approving investigational product (IP) temperature excursions to ensure release or rejection of IP in a timely manner
  • Supporting clinical inspections conducted by regulatory agencies, including sponsor inspections, clinical investigative site inspections, and contract research organization (CRO) inspections.
  • Participating in review and approval of clinical study documents and clinical SOPs / Guidance Documents
  • Maintaining the GCP regulatory surveillance program
  • Managing study specific Clinical Study Audit Plans (CSAP) compliance for assigned program by using risk-based approach for the company’s clinical studies


QUALIFICATIONS

  • Ability to travel
  • Ability to perform GCP Audits
  • Advanced Microsoft Office applications (Word, Excel, Power Point)
  • Thorough understanding of Quality Systems that supports GCP quality activities
  • Minimum 5+ years’ experience in clinical stage pharmaceutical companies
  • Experience developing GCP processes for the best industry practices and training personnel


EDUCATION

  • B.S. / B.A. degree in biological sciences, pharmacy, or related discipline