Quality Assurance Auditor

Work Schedule: Standard (Mon-Fri) Environmental Conditions: Office Job Description: Join Us as a Quality Assurance Auditor III - Make an Impact at the Forefront of Innovation. The Quality Assurance Auditor III leads complex and/or multi‑department internal and/or external audits to ensure compliance with established quality assurance processes, standards, global regulatory guidelines and/or client contractual obligations. This role identifies issues impacting quality and regulatory compliance, determines the root cause of non‑conformance, and develops strategies to address these issues. The Quality Assurance Auditor III may perform technical document reviews and other GxP activities in support of project work or company processes. Additionally, the Quality Assurance Auditor III provides finished audit reports to management, plans and delivers billable quality services for clients and projects, and may serve as the client contact. What You’ll Do Conduct and/or lead a variety of client, internal or GxP audits and regulatory inspections as requested by senior management. Lead directed site audits, facility, vendor and/or sub‑contractor audits. Provide GxP consultation and support to project teams and external clients. Lead process audits and may participate as a co‑auditor in more complex system audits. Perform other types of QA audits or activities (e.g. database audits, clinical study report audits, sample results tables, process improvement). Serve as a resource to operational departments on audit or quality assurance subject matter. Prepare and present audit findings and/or other related information at departmental, internal operations or client meetings. Provide mentorship and guidance to junior auditors. Education & Experience Requirements Bachelor’s degree or equivalent and relevant formal academic/vocational qualification. Previous QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years). In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills, Abilities Detailed knowledge of GxP and appropriate regional research regulations and guidelines. Demonstrated proficiency and demonstrated leadership of a range of project‑based or internal GxP audits and vendor audits to high standards required by management. Excellent oral and written communication skills. Strong problem‑solving, risk assessment and impact analysis abilities. Solid experience in root cause analysis. Above average negotiation and conflict management skills. Flexible and able to multi‑task and prioritize competing demands/work load. Valid driver’s license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel. Working Conditions and Environment Work is performed in an office/laboratory and/or a clinical environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office equipment. Personal protective equipment required such as protective eyewear, garments, and gloves. #J-18808-Ljbffr