Quality Assurance Associates I Or II Open Pool

Job description

Posting Detail Information


Working TitleQuality Assurance Associates I Or II - Open Pool

Position LocationFort Collins, CO

Work LocationPosition is fully in-office/in-person

Research Professional PositionYes

Posting Number202500716AP

Position TypeAdmin Professional/ Research Professional

Classification Title

Number of Vacancies

Work Hours/Week

Proposed Annual Salary Range$45,000 - $80,000

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.


+ Review our detailed benefits information here.

(https://hr.colostate.edu/wp-content/uploads/sites/25/2021/01/benefits-summary-afap.pdf)

+ Explore the additional perks of working at CSU here.

+ For the total value of CSU benefits in addition to wages, use our compensation calculator (https://hr.colostate.edu/total-compensation-calculator/) .

+ Lastly, click here for more information about why Fort Collins is consistently ranked in the top cities to live in (https://hr.colostate.edu/prospective-employees/our-community/) !


Desired Start Date

Position End Date (if temporary)

To ensure full consideration, applications must be received by 11:59pm (MT) on12/31/2025

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 Iis 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 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 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.



Essential Duties



Application Details


Special Instructions to Applicants
Please submit a cover letter outlining your areas of experience, resume, and the names and contact info of three professional references.

References will not be contacted without prior notifications of candidates.

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.

The pool is valid through 12/31/2025.

Individuals wishing to be considered beyond this date must reapply.

CSU is committed to full inclusion of qualified individuals.

If you are needing assistance or accommodations with the search process, please reach out to the listed search contact.


Conditions of EmploymentPre-employment Criminal Background Check (required for new hires)

Search ContactDarragh Heaslip, Darragh.Heaslip@colostate.edu

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.

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

+ Cover Letter

+ Resume

Optional Documents

Required Skill Profession

Other General