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Quality Assurance Manager
Unique career opportunity with growing organization.
You will be relied upon to manage internal compliance
audits and review and approve OOS, OOT and Deviation
Discrepancy Investigations. It will be up to you to ensure
that client audits and site visits are appropriately
scheduled upon request and you will be called upon to host
host client audits and respond to client audit
observations. Additionally, you will use your expertise to
organize and provide cGMP/GLP training, inspections and
serve as cGLP activist and guide members of laboratory
staff and management in compliance/regulatory issues and
the reporting of unresolved compliance issues to the
laboratory management and QA management. You will have the
opportunity to host monthly quality management meetings
(pertaining to the presentation of quality metrics)and
manage CAPA follow ups for the site.
Also, you will play an important role in the reporting of
both concerns and improvements/accomplishments to QA
management and appropriate department managers and have the
opportunity to assist and even lead the facilitation of
regulatory inspections (e.g. FDA/EPA). Important SOP
management will also be part of your contributions.
You will need a Bachelor Degree in Biology, Microbiology or
Chemistry and five years experience in an FDA regulated
field, preferably pharmaceuticals or a contract testing
lab, with a proven track record as a supervisor or manager
of a team.
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| Additional Information |
Position Type:
Employee
Ref Code: QA/SA |
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