Pharm-Olam, LLC is a mid-size Contract Research Organization (CRO) that has a massive global reach. We are a company that strives to deliver cost-effective, quick-to-market clinical services in today’s emerging marketplace. Pharm-Olam has one of the largest global footprints of any CRO today and we are committed to not only maintain our standard, but to continue to strengthen our presence even further. We offer a unique working environment with a global team culture, competitive salary and benefits package.
The Senior Auditor will have an in-depth understanding of Clinical Trials and Clinical Development, combined with an in-depth knowledge of ICH-GCP, appropriate GxP compliance standards, other international GCP regulations / standards (e.g. as applicable: EU Clinical Trial Directive and Regulation 536/2014 when effective, US FDA Code of Federal Regulations) and, as required/ applicable, local relevant GCP guidance, laws and regulations and appropriate processes, which allows the individual to plan and conduct internal and external audits independently and to be able to mentor less experienced auditors. The auditor will promote compliance with relevant GXP standards, international and local laws and regulations within the company and maintain behaviours which support: accountability, timeliness, transparency and consistency set a good example to others.
Auditors must be detail oriented, able to understand business needs and able to translate them in the daily work and responsibilities, exhibit a high degree of flexibility and initiative, demonstrate the ability to follow up on multiple tasks and projects, and able to manage confidential information appropriately. The Senior auditor will contribute to the execution of the QA audit schedules as assigned, performing internal and client contracted/billable audits, providing GxP and quality consultancy to internal/external clients where appropriate and will facilitate client audits and/or assist with regulatory inspections, as assigned.
This is a full-time, direct hire role for an experienced Senior QA Auditor with GCP & CRO experience. Position can be home based, however, candidate must reside in or near Texas. Candidates must be open to travel (exceptions in place during pandemic) and have auditing, regulatory and government inspection experience. #LI-Remote
QUALITY MANAGEMENT SYSTEM
CLIENT AUDIT & INSPECTION MANAGEMENT
Please apply online at www.pharm-olam.com/careers
Pharm-Olam, LLC provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
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