Job Information
Colorado State University Quality Assurance Associates I, II, or III - Open Pool in Fort Collins, Colorado
Posting Detail Information
Working TitleQuality Assurance Associates I, II, or III - Open Pool
Position LocationFort Collins, CO
Work LocationPosition qualifies for hybrid/in-office work
Research Professional PositionYes
Posting Number202301090AP
Position TypeAdmin Professional/ Research Professional
Classification Title
Number of Vacancies
Work Hours/Week
Proposed Annual Salary Range$40,000 - $90,000
Employee Benefits
Colorado State University ( CSU ) is committed to providing employees with a strong and competitive benefits package that supports you, your health, and your family. Visit CSU’s Human Resources website for detailed benefit plan information for permanent full-time and part-time faculty and administrative professional employees in the following University benefit areas:https://hr.colostate.edu/hr-community-and-supervisors/benefits/benefits-eligibility/andhttps://hr.colostate.edu/prospective-employees/our-perks/.
Desired Start Date
Position End Date (if temporary)
To ensure full consideration, applications must be received by 11:59pm (MT) on05/31/2024
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 an FDA compatible Quality System using 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 and administrative work is expected in Biosafety Level 2 laboratories and may be expected in BSL -3 laboratories. In addition, work related to quality assurance and document control in support of GMP manufacturing, testing, and Non-Clinical 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 perform as part of a team and think critically through instructions, problem solve and make professional judgments with regard to regulatory compliance, quality and continuous improvement paradigms.
The different position level(s) require escalating levels of experience in the understanding and application of scientific concepts and experience in a Biopharmaceutical manufacturing environment.
Required Job Qualifications
Required qualification, rank and salary determined by specific position to be filled.
Minimum Qualifications:
Level Iis for individuals with a Bachelor’s degree in biology, chemistry, or related science, OR a Bachelor’s degree in an unrelated field plus 1 year of professional experience related to the specific assignment or 1 year experience in a contract manufacturing organization.
Level IIis 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 no experience, OR a Bachelor’s degree in an unrelated field plus 3 years of professional experience in a contract manufacturing organization.
Level III is for individuals with a Bachelor’s degree in biology, chemistry, or related science and 4 or more years of relevant professional experience, OR a Master’s degree with 2 years experience, OR a Bachelor’s degree in an unrelated field plus 5 years of professional experience in a contract manufacturing organization.
The successful candidate must be legally eligible to work in the U.S. at time of application; the Infectious Disease Research Center will not provide visa sponsorship for these positions.
Preferred Job Qualifications
Relative experience commensurate with the specific position to be filled in a GMP quality system or document control.
Relative experience commensurate with the specific position to be filled in a contract manufacturing or other 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 .
Biosafety Level 2/3/or working in high containment facility.
Diversity Statement
Reflecting departmental and institutional values, candidates are expected to have the ability to advance the Department’s commitment to diversity and inclusion.
Essential Duties
Application Details
Special Instructions to Applicants
Please submit a resume/CV, a cover letter outlining your areas of expertise, and the names and contact info of three professional references.
References will not be contacted without prior notifications of candidates.
The pool is valid through 05/31/2024. Individuals wishing to be considered beyond this date must reapply.
Conditions of EmploymentPre-employment Criminal Background Check (required for new hires)
Search ContactDarragh Heaslip, Darragh.Heaslip@colostate.edu
EEO Statement
Colorado State University is committed to providing an environment that is free from discrimination and harassment based on race, age, creed, color, religion, national origin or ancestry, sex, gender, disability, veteran status, genetic information, sexual orientation, gender identity/expression, or pregnancy in its employment, programs, services and activities, and admissions, and, in certain circumstances, marriage to a co-worker. The University will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. Colorado State University is an equal opportunity and equal access institution and affirmative action employer fully committed to achieving a diverse workforce and complies with all Federal and Colorado State laws, regulations, and executive orders regarding non-discrimination and affirmative action. TheOffice of Equal Opportunity (https://oeo.colostate.edu/) is located in 101 Student Services.
The Title IX Coordinator is the Director of the Office of Title IX Programs and Gender Equity, 123 Student Services Building, Fort Collins, CO 80523-0160, (970) 491-1715,titleix@colostate.edu.
The Section 504 and ADA Coordinator is the Director of the Office of Equal Opportunity, 101 Student Services Building, Fort Collins, CO 80523-0160, (970) 491-5836,oeo@colostate.edu.
The Coordinator for any other forms of misconduct prohibited by the University’s Policy on Discrimination and Harassment is the Vice President for Equity, Equal Opportunity and Title IX, 101 Student Services Building, Fort Collins, Co. 80523-0160, (970) 491-5836,oeo@colostate.edu.
Any person may report sex discrimination under Title IX to theOffice of Civil Rights, Department of Education (https://www2.ed.gov/about/offices/list/ocr/docs/howto.html) .
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.
References Requested
References Requested
Minimum Requested3
Maximum Requested3
Supplemental Questions
Required fields are indicated with an asterisk (*).
Applicant Documents
Required Documents
Resume or CV
Cover Letter
Optional Documents