Quality Assurance Associate I

Colorado State University • Fort Collins, CO

8d • $50,000 - $65,000

About The Position

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/

Requirements

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

Nice To Haves

• 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.

Responsibilities

• 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.

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.
• Review our detailed benefits information here.
• Explore the additional perks of working at CSU here.
• For the total value of CSU benefits in addition to wages, use our compensation calculator.
• Lastly, click here for more information about why Fort Collins is consistently ranked in the top cities to live in!

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 1-10 employees