Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
JOB CODE: QUA.QAAU.P06
JOB PROFILE: Clinical Auditing Specialist III
BAND: 6
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.
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:
- Lead the audit response process review (i.e., root cause analysis, CAPA and effectiveness check) for a variety of client audits (mainly to clinical sites), as well as internal or GxP audits and regulatory inspections as requested by senior management
- Support the clinical team during the response process (i.e., root cause analysis, CAPA and effectiveness check) to a variety of client audits (mainly to clinical sites), as well as internal or GxP audits and regulatory inspections as requested by senior management
- Provide GxP consultation and support to project teams and external clients
- Contacted by others to serve as a resource to operational departments on audit or quality assurance subject matter
- Conduct and/or lead a variety of client, internal or GxP audits and regulatory inspections as requested by senior management, as required
- Lead directed site audits, facility, vendor and/or sub-contractor audits, as required
- Lead process audits and may participate as a co-auditor in more complex system audits, as required
- Perform other types of QA audits or activities (e.g. database audits, clinical study report audits, sample results tables, process improvement), as required
- Prepare and present audit findings and/or other related information at departmental, internal operations or client meetings
- Provide mentorship and guidance to junior auditors
REQUIREMENTS:
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 GCP and appropriate regional research regulations and guidelines
- Demonstrated proficiency and led a range of project based or internal GCP audits and vendor audits to high standards required by management
- Demonstrated proficiency in providing support and feedback to clinical teams during root cause analysis, CAPA and effectiveness check reviews
- 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 remotely (home-based) or in an office /and/or a clinical environment.
- Exposure to electrical office equipment.