Job Description
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.
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Summary of role
Conducts complex internal and/or external audits to ensure compliance with established quality assurance processes, standards, global regulatory guidelines and/or client contractual obligations. Identifies issues impacting quality and/or regulatory compliance, supports determination of root cause of non-conformance and assists in developing strategies to address issues. May perform technical document review and other GxP activities in support of project work or company process. Provides finished audit reports to management. Plans and delivers billable quality services for clients and projects
A day in the life:
- Conducts and/or leads a variety of client, internal or GxP audits and regulatory inspections as requested by senior management
- Performs directed site audits, facility, vendor and/or sub-contractor audits
- Provides GxP consultation and support to project teams and external clients
- Leads process audits and may participate as a co-auditor in more complex system audits
- Performs other types of QA audits or activities (e.g. database audits, clinical study report audits, sample results tables, process improvement)
- Serves as a knowledgeable resource to operational departments on audit or quality assurance subject matter
- Prepares and presents audit findings and/or other related information at departmental, internal operations or client meetings•
Education and Experience:
- 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 2+ years')
- GCP/Auditing Experience
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 and Abilities
- GCP experience
- Experience working in GCP Environment
- Auditing experience
- 25% travel required domestically (possibly internationally)
Our 4i Values:
Integrity - Innovation - Intensity - Involvement
If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs, submit your application - we'd love to hear from you!