About this Quality Assurance Associate I role at Colorado State University
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.
Minimum Qualifications
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.
Preferred Qualifications
Experience working within a cGMP quality system.
Experience working in a contract manufacturing or similar regulated environment.
Experience working in BSL-2 or BSL-3 clean room spaces.
Application Instructions
To apply, please upload a resume and cover letter. Applications will be reviewed as hiring needs arise, and qualified applicants may be contacted by individual faculty members if a suitable opportunity becomes available. This pool will remain open and continue collecting applications until September 30, 2026. Applicants wishing to be considered beyond this date must reapply.
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.
Employee Benefits
Colorado State University is not just a workplace; it’s a thriving community that’s transforming lives and improving the human condition through world-class teaching, research, and service. With a robust benefits package, collaborative atmosphere, and focus on work-life balance, CSU is where you can thrive, grow, and make a lasting impact.
Background Check Policy Statement
Colorado State University strives to provide a safe study, work, and living environment for its faculty, staff, volunteers and students. To support this environment and comply with applicable laws and regulations, CSU conducts background checks for the finalist before a final offer. The type of background check conducted varies by position and can include, but is not limited to, criminal history, sex offender registry, motor vehicle history, financial history, and/or education verification. Background checks will also be conducted when required by law or contract and when, in the discretion of the University, it is reasonable and prudent to do so.
EEO
Colorado State University (CSU) provides equal employment opportunities to all applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.