Auditor - GLP
BioSpace · King of Prussia, PA · 3 wk ago
FinanceFull-time
Main Responsibilities
- Cover assigned external audits of non-clinical facilities and safety laboratories.
- Develop and issue comprehensive Audit Reports, categorizing findings by risk level and providing recommendations for corrective and preventive actions (CAPA) related to trial conduct and data integrity.
- Identify non-compliance trends and systematic risks within the Non-clinical (GRLP/GLP/GCLP) discipline, communicating these findings to line management and clinical functional leads to ensure trial robustness.
- Support initiatives to improve standard operating procedures (SOPs) for audit conduct and partner with stakeholders to develop risk-based, compliant solutions for non-clinical trial management.
- Maintain up-to-date knowledge of global GLP regulations (ICH Safety Guidelines) and industry trends, identifying new requirements to ensure a high level of quality is maintained across all non-clinical development programs.
Position Qualifications & Experience
- Academic Background: BS degree in relevant biological science, science, or related discipline.
- Professional Experience: 3+ years of Quality Assurance experience within a pre-clinical and safety laboratory environment, demonstrating a strong understanding of preclinical trials, monitoring, and regulatory frameworks.
- Audit Expertise: Experience in preclinical audit and inspection management, with a clear understanding of the requirements for quality assurance in the preclinical research discipline.
- Communication Skills: Excellent interpersonal and negotiation skills, with the ability to work effectively with external vendors providing relevant services.
- Knowledge: Directives 2004/9/EC and 2004/10/EC (GLP Directives), 21 CFR Part 58 – Good Laboratory Practice (GLP), OECD principles of GLP, ICH Safety Guidelines, ICH M3(R2) Guideline, ICH M10 Guideline.
- Organizational Agility: Strong analytical and problem-solving skills, with the ability to work with limited supervision and manage a schedule that includes up to 50% travel.