Bachelor's degree in the Sciences or a field related to the responsibilities of the assignment with 0-1 years of experience; OR
Bachelor's degree in an unrelated field plus at least 1-2 years of professional experience related to the specific assignment.
Experience working within a cGMP quality system.
Quality Assurance Associate I at Csusystem
Experience working in a contract manufacturing or similar regulated environment.
Experience working in BSL-2 or BSL-3 clean room spaces.
Application Instructions
Please note, applicants may redact information from their application materials that identifies their age, date of birth, or dates of attendance at or graduation from an educational institution.
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Background Check Policy Statement
EEO
Benefits
Vision insurance
Additional Information
Job Description
Position Summary
The QA Associate I primary role is to assist in the planning, preparation and compliance oversight of laboratory-based activities related to the production of cGMP biological material for use in early Phase Clinical trials. Additional roles include assisting with the maintenance of the overarching quality management system and ensuring document integrity and compliance to good documentation practices.
A detailed description of the Infectious Disease Research Center is available on the department website: https://www.research.colostate.edu/idrc/
Salary Range
$50,000 - $65,000
Essential Job Duties
Review executed cGMP documentation including batch production records and testing forms for completeness and compliance with applicable regulatory requirements.
Control and issue documents required for operations and project work.
Assist in writing and updating QA policies and procedures based on effective reviews.
Actively participate in the Quality management system; ensuring all training is current and complete and adhere to safety/biosafety practices and policies.
Perform other duties as required.
Conditions of Employment
Standard background check expected. Expected to work under BSL-3 conditions and may require work with CDC Select Agents.
Supervision
None expected.
Csusystem · Fort Collins, CO