QA Auditor II - Remote

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Thermo Fisher Scientific

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Analytical Instruments • Laboratory Supply Chain Programs and eCommerce • Laboratory Equipment • Lab Services • Specialty Diagnostics

10,000+

Description

• Conduct complex internal and external Clinical Research Site audits to ensure compliance with established quality assurance processes, standards, global regulatory guidelines, and client contractual obligations. • Identify issues impacting the quality and/or integrity of clinical research programs, determine root cause of non-conformance and develops strategies to address issues. • Perform technical document review and other GCP practice activities in support of clinical development programs. • Provide audit reports to management. • Plan and deliver quality services including contracted quality assurance audits, internal site audits, laboratory and file audits for clients and projects. • Lead process/quality improvement initiatives. • Mentor peers. • Develop tools and other materials for tracking of compliance management activities and analyze trends. • Upon request, support regulatory inspections and/or client audit hosting.

Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification. • Previous Clinical Site Auditing experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years) or equivalent combination of education, training, & experience. • Must have GCP and auditing experience for clinical trials, in order to qualify for this role! • Thorough knowledge of applicable GCP and appropriate regional regulations. • Strong knowledge of the clinical trial process. • Experience with study-specific (investigator site) audits or other GP audits, could also include process and vendor audits. • Experience in root cause analysis and CAPA development. • Well-rounded knowledge of SOPs and WIs. • Excellent oral and written communication skills (including appropriate use of medical and scientific terminology). • Strong attention to detail. • Effectively works independently or in a team environment. • Strong problem-solving skills, risk assessment and impact analysis abilities. • Above average negotiation and conflict management skills. • Flexible and able to multitask and prioritize competing demands/workload. • Strong computer skills; ability to learn and become proficient with appropriate software. • Valid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel. • Hosting client audits and/or regulatory inspections experience is a plus. • Auditing database, eTMF, and Clinical Study Report experience is a plus. • Training/mentoring of peers experience is a plus.