Quality Assurance Associate I

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.

$50,000 – $65,000

• 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.

Standard background check expected. Expected to work under BSL-3 conditions and may require work with CDC Select Agents.

None expected.

• 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.
• Experience working in a contract manufacturing or similar regulated environment.
• Experience working in BSL-2 or BSL-3 clean room spaces.

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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.

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.