Sr Quality Auditor, GCP Auditor – job post ,vacancy
NBScience is helping one of our favorite clinical research services clients in the EU Market add an GCP Auditor to one of their internal audit verticals. This team is lead by someone we know well and really respect personally . This team is making waves in the business globally and is looked at as a true internal consultant to the other areas of the business.
Competitive salary + Bonus Competitive Benefits
About the Job
As a member of the quality team, the Sr Quality Auditor, GCP works collaboratively with groups throughout the organization to ensure compliance with regulatory requirements and to support a diverse array of projects and initiatives. This position contributes to QA activities across multiple quality system requirements, such as CLIA/CAP, GCP, ISO and FDA regulated environments.
Perform periodic audits of Good Clinical Practice activities which may include, but is not limited to, BioPharma and Clinical Operations procedures, processes, records, and reports.
Prepare reports of audit and inspection observations.
Discuss audit and inspection findings with management staff to develop appropriate corrective and preventive actions where appropriate.
Assist with external audits performed by regulatory/inspection agencies or BioPharma/Clinical Operations Partners, as required.
Assist with the compilation of audit findings for management purposes.
Maintain current and accurate records of all relevant communications, audits, corrective action plans, and CAPA effectiveness monitoring, as required.
Demonstrate strong proficiency in the application of the Corrective and Preventive Action (CAPA) system to ensure action, closure and verification of effectiveness of solutions applied to root cause issues originating from internal/external quality audits or other sources.
Maintain familiarity with BioPharma and Clinical Operations and relevant Laboratory operating and quality assurance/quality control procedures to effectively perform GCP quality assurance functions.
Support, maintain and continually improve Quality System.
Maintain availability to work outside of a regularly scheduled shift.
Travel domestically up to 20% of the time.
Support other duties, as assigned.
Bachelor’s Degree or equivalent
4+ years of of clinical monitoring/Quality Assurance experience in the pharmaceutical, biotechnology, or diagnostic industries
GCP AUditor certificate
ASQ Quality Auditor certified
Auditing Experience (Clinical Investigator Site / Vendor)
Experience with Vendor Management
Experience with managing GCP activities across multiple quality system requirements (e.g. operating under FDA, ISO, CLIA and CAP)
Experience or familiarity with Companion Diagnostics or Clinical Lab operations
Scientific background in molecular biology and/or NGS
Understanding/working knowledge of ICH and GCP guidelines
Ability to manage multiple projects and work independently
Process-oriented, with the ability to demonstrate good judgment and decision-making
Ability to identify quality issues and effectively interface with internal and external teams
Strong attention to detail and the ability to manage multiple priorities with aggressive timelines
Strong written and communication skills
Ability to communicate clearly and concisely with all stakeholders
Understanding of HIPAA and importance of privacy of patient data
Commitment to FMI values: patients, innovation, collaboration, and passion
CV by email: firstname.lastname@example.org