QA Auditor II at Thermo Fisher Scientific in Richmond, Virginia

Job Description:

Work Schedule

Standard (Mon-Fri)



Environmental Conditions

Office



Job Description



Company Name: PPD Development, L.P.


Position Title: QA Auditor II


Location: 2244 Dabney Road, Richmond, VA 23230


Summary of Duties: Conducts complex internal and external audits to ensure compliance with established quality assurance processes, standards, global regulatory guidelines, and client contractual obligations. Identifies issues impacting quality and regulatory compliance, supports determination of root cause of nonconformance and assists in developing strategies to address issues. Performs 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. Conducts and leads a variety of client, internal or GxP audits and regulatory inspections as requested by senior management. Performs directed site audits, facility, vendor and sub-contractor audits. Provides GxP consultation and support to project teams and external clients. Leads process audits and participate as a co-auditor in more complex system audits. Performs other types of QA audits or activities such as 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 other related information at departmental, internal operations, and client meetings.


Qualifications: Master's Degree in Biotechnology, Biomedical Engineering, or related field and one (1) year of experience as a Senior Scientist, R&D Executive, Lead QC Officer, or a related role. In the alternative, the employer will accept a Bachelor's Degree in Biotechnology, Biomedical Engineering, or related field and Three (3) years of experience as a Senior Scientist, R&D Executive, Lead QC Officer, or a related role. Must have one (1) year of experience with the following: Applicable GxP and appropriate regional regulations to ensure continued compliance with local, federal, international regulations/standards; GXP Audits to ensure processes and policies adhere to local, federal, international regulations/standards; SOPs and WPDs development, review, and application; Medical and scientific terminology; Auditing principles and functions and how to apply them to GXP principles; Understanding of complex scientific processes, assay/method development, clinical trial process and how these apply to data generation that support vaccine clinical trials and the applicable GXP regulations.


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