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ОБЩЕСТВО С ОГРАНИЧЕННОЙ ОТВЕТСТВЕННОСТЬЮ "ЦЕНТР НАЦИОНАЛЬНЫХ ИНТЕЛЛЕКТУАЛЬНЫХ СИСТЕМ" ИНН: 9704271170
описание
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
задачи
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.
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)
Contacted by others to 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
требования
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.
Detailed knowledge of GxP and appropriate regional research regulations and guidelines
Demonstrated proficiency and led a range of project based or internal GxP audits and vendor audits to high standards required by management
Working knowledge of Good Manufacturing Practice (GMP) requirements
Previous experience working in a laboratory environment is preferred
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
условия
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.
When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.
Apply today to help us deliver tomorrow’s breakthroughs.