FierceBiotech and FiercePharma Jobs
GCP Auditor - DOR BioPharma, Inc.
Nov 26
Location: Ewing, NJCategories: Clinical
Website: http://www.dorbiopharma.com
Position Description
POSITION SUMMARY:
Under the direct supervision of the President/CEO, the GCP Auditor is accountable for the quality oversight of one or more clinical trials. In conjunction with the Director, Regulatory & Clinical Operations, this position will develop and independently implement initiatives aimed to ensure the successful and quality completion of the Phase 1, 2 and 3 clinical trials and all related clinical trial milestones in accordance with FDA, ICH and corporate standards. The lead product being evaluated in the clinical studies, orBec® (oral beclomethasone dipropionate), represents a promising new treatment for GI GVHD (gastrointestinal graft-versus-host disease).
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Responsible for activities involving Quality Assurance/Quality Control and compliance with applicable regulatory requirements.
• Responsible for ensuring that clinical trials are conducted in compliance with Good Clinical Practices (GCPs) and other applicable regulatory requirements.
• Ensure that trial data is generated, documented and reported in compliance with Good Clinical Practices (GCPs) and other applicable regulatory requirements.
• Conduct vendor, clinical site, file or data audits to ensure compliance with GCP’s. The QA Auditor will conduct internal audits to ensure compliance with Company SOPs, GCP’s, and other applicable regulatory requirements, prepare audit reports and corrective action plans and coordinate external consultant audits.
• The QA Auditor will also review (QC) internal documentation for compliance to Company SOPs, GCPs, and other applicable regulatory requirements, assist in the preparation for and execution of international or domestic regulatory agency inspections and develop/ implement/revise Quality Assurance SOPs.
• The QA Auditor will travel as needed. Estimated to be 25-30%.
ADDITIONAL DUTIES:
As assigned.
EDUCATIONAL REQUIREMENTS (degree, license, certification):
• A bachelor’s degree in a Life Science preferred or relevant work experience.
• Certified Quality Auditor (CQA) and/or Regulatory Affairs Certification is preferred but not required.
EXPERIENCE:
• 3 to 5 years experience in the pharmaceutical or biotechnology industry or clinical research environment.
• Minimum of 3 years experience as a QA Auditor is a must.
• Experience and knowledge of GCPs/SOPs preferably within a pharmaceutical or research environment is required.
• Previous experience in all Phases of clinical studies, desirable. Extensive experience with 3 study(ies) a must.
PHYSICAL REQUIREMENTS / WORKING CONDITIONS of POSITION:
Not applicable.
OTHER SKILLS AND ABILITIES:
• Demonstrated experience managing multiple projects simultaneously with aggressive timelines.
• Knowledge and experience in auditing clinical trial data.
• Electronic Data Capture (EDC) systems and 21CFR11 computer system validation experience.
• Experience and demonstrated ability to manage at a high level of productivity with minimum infrastructure.
• Experience in developing and making formal presentations.
• Experience in budget planning, management and reconciliation.
• Proficient knowledge of Excel, problem solving and analytical skills required.
• Experience in outsourcing management.
• Ability to function well in a cohesive management team, matrix environment, with strong goal and results orientation.
• Proven verbal and written communication skills.
