QA Auditor III ISQA- Fully remote!

Work Schedule
Standard Office Hours (40/wk)

Environmental Conditions
Office

Job Description

Thermo Fisher Scientific Inc. is a premier company that is dedicated to enabling our customers to make the world healthier, cleaner, and safer. We are a team of 100,000+ colleagues who share a common set of values - Integrity, Intensity, Innovation, and Involvement. Together, we work to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need.

Summarized Purpose:

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. Identifies issues impacting quality and/or regulatory compliance, determines root cause of non-conformance and develops 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 and may serve as the client contact.

Essential Functions:

• Conducts and/or leads a variety of client, internal or GxP audits and regulatory inspections as requested by senior management
• Leads 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)
• Contacted by others to serve as a 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
• Provides mentorship and guidance to junior auditors

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!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com (bolded) Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Accessibility/Disability Access (bolded) Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255. Please include your contact information and specific details about your required accommodation to support you during the job application process.

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