Quality Assurance Specialist III
Quality Assurance Specialist III
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Colorado State University is seeking a Quality Assurance (QA) Specialist III to support the CSU Quality Assurance Program and assure under the direction of the QA Manager that CSU is in full compliance with institutional and federal Good Practice GXP policies and regulations on behalf of the Institutional Official (the Vice President for Research) and the Provost. The QA Specialist III maintains systems and infrastructure required for compliance with GXP activities. This position requires strong knowledge of process and analytical development clinical pharmaceutical and biologic manufacturing nonclinical laboratory processes and knowledge of non GXP and GXP quality requirements for pharmaceuticals devices biologics and other regulated categories. This position is responsible for ensuring under the direction of the QA Manager that GXP research quality assurance needs are met across Colorado State University CSU colleges institutes laboratories and departments. This position ensures coordinating with the QA manager that tasks related to planning coordination management and establishment of processes and procedures to assess and monitor the conduct and quality of GXP activities conducted at CSU are identified and accomplished to meet business needs requirements. The person in this position will focus on continuous improvement projects using approved tools design control and validations to ensure efficiency and adherence to federal state and local regulations along with industry guidelines and applicable CSU policies and procedures. Under the direction of the QA Manager the QA Specialist III reviews interprets applies and provides key guidance on a variety of regulations or guidance documents including (but not limited to): FDA / EPA GLP FDA GCP FDA GMP CFR 21 Part 11 Gamp5 ISO 9001:2008 This position is expected to be onsite a majority of work time. The VPR Office supports flexible work arrangements for employees including limited teleworking privileges. Read more here: .
Required Experience:
Unclear Seniority
Employment Type
Full Time
