Work schedule
other
environmental conditions
office
job description
join us as quality assurance auditor ii - and enhance our clinical auditing processes by ensuring regulatory compliance and quality standards.
What you’ll do
conduct and/or lead a variety of gxp qualification and routine vendor audits, as requested by senior management, including but not limited to on-site, virtual and remote audits of service providers used in clinical trials with or without technology components
perform directed vendor audits
may perform clinical investigator site
provide gxp consultation and support to internal and external clients
serve as a knowledgeable 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
education and experience:
bachelor's degree or equivalent and relevant formal academic / vocational qualification
previous qa and gxp vendor auditing experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years’).
Fluent in english, spanish and portuguese
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:
solid knowledge of the clinical trial process
thorough knowledge of gxp and appropriate regional research regulations and guidelines
demonstrated proficiency and led a range of gxp vendor audits to high standards required by management
excellent oral and written communication skills (including appropriate use of medical and scientific terminology)
strong attention to detail
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