About the Company
Our client, a biotechnology company focused on unique, revolutionary treatments for patients is currently seeking a GCP Auditor for a temp-to-perm role in their Greater Boston location.
The GCP QA Auditor will be responsible for defining the GCP audit schedule to ensure external and internal entities (including GcLP laboratories) and contract organizations meet all defined regulatory requirements. Key responsibilities include:
- Scheduling, preparing and conducting audits in support of GCP as directed.
- Assisting QA management in the development and implementation of procedures and working practices to ensure continuous quality improvement.
- Planning, tracking and overseeing GCP and GcLP audits of external contract laboratories and CROs, and internal audits against approved procedures.
- Working with Clinical Operations to oversee all appropriate clinical activities, reviewing all audit reports and corrective actions generated from the audits and ensuring compliance of clinical operations and initiatives with all applicable regulations and standards.
- Assisting in resolving compliance issues at clinical sites, clinical vendors, and laboratories; and providing assessment of the impact of any deficiencies.
- Maintaining relevant knowledge of both local and international auditing and appropriate GxP requirements and developments as they impact company SOPs and compliance with GxP, and communicating these to the QA team and QA management, as applicable.
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- Bachelor’s degree required.
- 3+ years of direct audit experience in GCP required
- Must possess knowledge of US FDA regulations, International Conference on Harmonization (ICH) and EU GCP regulations and guidelines
- Candidate must have knowledge and experience of appropriate GCP compliance and other applicable regulations and laws.
- Demonstrated capabilities to assist QA management in the implementation of systems and perform GCP audits in accordance with company processes.
- Candidate should exhibit a high degree of flexibility and initiative, demonstrate the ability to follow up on multiple tasks and projects, and possess the ability to handle confidential information.
- Ability to identify improvements that enhance the quality and clarity of audit reports.
- Must be able to exercise judgment in ensuring that written procedures are followed and in evaluating quality systems, processes, procedures, and protocols for compliance.