Senior GCP Auditor
Veristat is expanding our global footprint, from our home office in Boston, up to Canada, down to RTP, and over to Taipei.
We do things differently than large CROs. Do you value scientific integrity and a collaborative team environment? If so, you will feel right at home here with dedicated opportunities to discuss your achievements and grow your career through quarterly feedback conversations.
We invite you to learn more about us at our website www.veristat.com.
The Senior GCP (Good Clinical Practices) Auditor is responsible for execution of the Audit Plan at Veristat. S/he will plan, conduct, report and follow up on all types of GCP audits, including internal audits, contracted audits and vendor audits. The Senior GCP Auditor will also provide support during sponsor audits and regulatory inspections and will support all relevant activities associated with Veristat’s Quality Management System.
As a Senior GCP Auditor You Will…
- Conduct various types of internal and contracted study and process / system audits per Veristat internal procedures, to ensure documentation and processes comply with regulations, GCP guidance, standards and standard operating procedures.
- Coordinate, support and host sponsor audits.
- Support the completion of responses to findings received from Sponsor Audits and Regulatory Inspections.
- Assist with and provide support during regulatory inspections.
- Coordinate and conduct on site and questionnaire vendor qualification audits.
- Coordinate and issue annual Vendor Risk Assessments.
- Issue audit reports in accordance with standard company format and timelines, ensuring clear communication of audit findings to project members and/or functional management.
- Escalate significant findings to Senior QA & Compliance Management.
- Provide guidance and support for Computer Systems Validation activities and audits.
- Prepare quality metrics for reporting of trends to support process improvement.
- Provide training on relevant quality management systems and/or GCP compliance.
- Participate in Quality Improvement Initiatives.
- Provide support to other assignments as directed by QA and Compliance.
Experience + Requirements
- Bachelor’s degree in Life Sciences or related field.
- ASQ-CQA or similar certification strongly preferred.
- 5+ years of relevant GCP auditing experience in a FDA Environment such as pharmaceutical, biotech or CRO company or similar environment required.
- Knowledgeable in relevant regulations and guidelines including 21CFR-Part11 and GCP.
- Fluent in Microsoft Project, Outlook, Word, Excel, and PowerPoint.
- Prior experience with electronic Quality Management Systems preferred