Regulatory Compliance Specialist
We have an immediate opening for a full-time regulatory compliance specialist at our facility in south austin, texas.
***please submit your reply along with your cv/resume attached as a word doc/pdf file over here.
***job summary:
we are a private laboratory providing stem cell processing and storage services. This position is responsible for reading and interpreting all applicable international, federal, state and local regulations for our industry and advising senior management on recommended actions to insure compliance with those regulations. The primary regulations applied to us are cfr title 21 section 2171.10 however there are others which are also relevant.
***specific knowledge of these are not required however it would provide a large advantage over other applicants.
***general knowledge and experience with fda, cglp, cgtp, osha, iso, and other regulatory structure is required. In addition to usa fda regulatory compliance this position would help to insure our compliance with the uk human tissue authority (hta) regulations as they apply to our industry.
***a successful candidate will have the following attributes:
some biological lab experience including mammalian cell culture is preferred
quality assurance experience is required.
regulatory compliance experience require however extensive experience working in a regulated lab may substitute depending on the circumstances.
have a bs degree with 5 year of relevant experience or an advanced degree with 2 year of relevant experience.
some previous personnel management experience is desired but not required.
be familiar with reading and writing sop’s, capa’s and risk analysis.
be familiar with conducting internal regulatory audits.
***please attach your cv/resume here to apply.
***note this full-time, on-site job position does not provide visa sponsorship.
+74 Other ResponsesOnline Compliance Software
We are looking to speak to customers of gan integrity. Gan integrity is an all-in-one compliance management solution for the chief compliance officer at large enterprises in highly regulated industries.
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this would be for a 1 hour paid phone consultation. Please respond to the following questions with your availability windows for a 1 hour phone consult in the next few days.
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2. Please list all vendors you evaluated in this process and why you selected gan integrity?
3. Please describe your ongoing day to day interaction with gan integrity today?
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