Colorado State University

Description of Work Unit

Founded in 1870, Colorado State University is among the nation’s leading research universities and enrolls approximately 32,000 undergraduate, graduate, and professional students. Located an hour north of the Denver metro area, Fort Collins is a vibrant community of approximately 157,000 residents that offers the convenience of a small town with all the amenities of a large city. Fort Collins is situated on the Front Range of the Rocky Mountains with views of 14,000 foot peaks, and offers access to numerous cultural, recreational, and outdoor opportunities.

CSU BioMARC is a nonprofit contract development and manufacturing organization focused on the production of biopharmaceutical materials for non-clinical, clinical, and commercial use under Biosafety Level 2, 3 and Select Agent biosecurity conditions. In addition to manufacturing and testing services, BioMARC offers product and process development services, which includes the creation of development programs focused on implementing cGMP regulations and biomanufacturing production scalability.

Position Summary

The Quality Assurance Associate is responsible for the implementation and execution of policies and procedures for the cGMP manufacturing of biologics. Individuals will be working within a cGMP compatible Quality System utilizing Quality Assurance approved SOPs, protocols and/or similar controlled documents.

Candidates must be able to physically enter cleanrooms that require specialized biocontainment protective gowning. Entry into and performing activities in Biosafety Level 2 (BSL) and/or BSL-3 laboratory spaces is expected. In addition, work related to quality assurance and document control in support of GMP manufacturing, testing, and non-GMP production/research may be assigned with the expectations that the employee make use of skills similar to those described above.

Successful candidates must be able to review and audit documentation for compliance to good documentation practices (GDP), data integrity, and to the technical requirements of directive documents (SOPs, protocols, directive documents, etc.). Candidates must be able to perform as part of a team and think critically through instructions, problem solve and make professional judgments about regulatory compliance, quality and continuous improvement paradigms.

The different position level(s) require escalating levels of experience in the understanding and application of quality, document control, and regulatory requirements in a GMP and non-GMP environment.

Required Job Qualifications

Required qualification, rank and salary determined by specific position to be filled.

Minimum Qualifications:

• Level I is for individuals with a Bachelor’s degree in biology, chemistry, or related science, OR a Bachelor’s degree in an unrelated field plus 0-1 year of professional experience related to the specific assignment or 0-1 year experience in a contract manufacturing organization.
• Level II is for individuals with a Bachelor’s degree in biology, chemistry, or related science and 2 or more years of relevant professional experience, OR a Master’s degree with 0-1 professional experience, OR a Bachelor’s degree in an unrelated field plus 3 or more years of professional experience in a contract manufacturing organization.

Successful candidate must be legally authorized to work in the United States by time of application.

Preferred Job Qualifications

• Relative experience commensurate with the specific position to be filled in a GMP quality system or management of cGMP documentation.
• Relative experience commensurate with the specific position to be filled in a contract manufacturing or similar regulated environment.
• Relative experience commensurate with the specific position to be filled in US code of federal regulation fields of GMP, GLP, and/or GXP.
• Experience in BSL-2 or 3 clean room spaces.

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.