Quality Approver

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POST DATE 9/3/2016
END DATE 12/19/2016

Confidential Company Boulder, CO

Boulder, CO
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #


* Review and approve exception investigation documentation.
* Provide guidance identifying potential product impact and determine final product disposition through exception report approval.
* Provides guidance on remediation and developing corrective and preventive action (CAPA) plans.
* Leads successful closure of CAPAs through collaboration with peers in operations and other departments.
* Provide cGMP training as required and guidance on event classification and proper actions to mitigate and limit potential product impact.

* Requires Bachelor's Degree in Scientific/Technical Field (i.e. Chemistry, Biology, Quality or Engineering).
* Minimum of 3years professional experience in Quality or Operations, primarily in a cGMP facility, or equivalent is needed to meet the objectives of this position.
* Requires thorough knowledge of cGMPs. Effective communication skills are required, both written and verbal.
* Effective project management skills and demonstrated ability to manage multiple competing priorities.