The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.
An American Company is seeking an Sr GCP Auditor in New York, NY.
The Senior GCP (Good Clinical Practices) Auditor is responsible for execution of the Audit Plan. 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 our Quality Management System.
Primary Duties + Responsibility:
• Conduct various types of internal and contracted study and process / system audits per 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.
Skills & Requirements
• Bachelor's degree in Life Sciences or related field required.
• 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.
You will be working with a professional recruiter who has intimate knowledge of the Information Technology industry and market trends . Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there's a position you really want, you're fully prepared to get it.
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Hays is an Equal Opportunity Employer.
Drug testing may be required; please contact a recruiter for more information.