Quality Assurance Associate II or Engineer I

Job Summary:

The Gates Institute at the University of Colorado Anschutz is seeking a full-time Quality Assurance Associate II or Engineer I to join the biomanufacturing facility (GBF) in Aurora CO. GBF is an academic Phase I cGMP contract manufacturing facility dedicated to the development and manufacture of novel biologics and cell therapies for early-phase clinical trials and serves as a core capability that differentiates the University in both regenerative medicine and traditional biotechnology.

Within the Gates Biomanufacturing Facilitys dynamic environment become a contributor to Quality Assurance GMP and non-GMP batch support and release activities.

The QA Associate II will support the preparation review and release of GMP and non-GMP cell therapy and biologic batches support scanning and archival of GMP and Non-GMP batches optimize the eQMS batch release system and surrounding SOPs and paper forms and monitor metrics to ensure batch disposition compliance. Additionally this position will support material release equipment management site training and other routine QA activities.

In addition to the responsibilities above a QA Engineer I will be responsible and accountable for Quality Assurance and compliance measures for Cell therapy and protein manufacturing GMP facility this includes overseeing QA evaluations for complex processes (ex. IND CMC SMC etc.) and driving continuous improvement initiatives for quality system. These GMP investigational therapies are being evaluated in Phase I clinical trials.

Key Responsibilities:

• Review Batch Records In-Process and Release testing data Chain of Custody forms Receiving Inspections Thawing and Infusion documentation related to GMP and Non-GMP batch releases

• Review and release incoming materials as well as kitted materials

• Support review and release of new equipment including Installation Qualifications (IQ) Operational Qualifications (OQ) and Processing Qualifications (PQ) as well as the review and release of annual preventative maintenance (PM) and calibration activities for existing equipment

• Monitor batch disposition compliance metrics and effectiveness

• Review protocols and reports related to INDs stability and other GMP and Non-GMP activities

• Support optimization of the eQMS related to core systems (e.g. quality events change controls CAPAs etc.) including drafting and revision of new and existing Policy and SOP documents

Work Location:

Onsite this role is expected to work onsite and is located in Aurora CO.

Why Join Us:

Join the Gates Biomanufacturing Facility and be part of a team turning cutting-edge science into real therapies for patients. At the GBF your work directly supports the development and manufacture of novel biologics and cell therapies advancing into early-phase clinical trials offering a rare opportunity to contribute to life-changing innovation at the intersection of academia and industry.

Why work for the University

We haveAMAZINGbenefits and offerexceptional amounts of holiday vacation and sick leave! The University of Colorado offers an excellent benefits package including:

• Medical: Multiple plan options

• Dental: Multiple plan options

• Additional Insurance: Disability Life Vision

• Retirement 401(a) Plan: Employer contributes 10% of your gross pay

• Paid Time Off: Accruals over the year

• Vacation Days: 22/year (maximum accrual 352 hours)

• Sick Days: 15/year (unlimited maximum accrual)

• Holiday Days: 15/year

• Tuition Benefit: Employees have access to this benefit on all CU campuses

• ECO Pass: Reduced rate RTD Bus and light rail service

There are many additional perks & programs with the CU Advantage.

Qualifications:

Minimum Qualifications:

Quality Assurance Associate II:

• A bachelors degree in a Biological Sciences discipline Engineering or a related field. Substitution: A combination of education and related technical/military/paraprofessional experience may be substituted for the bachelors degree on a year for year basis but not for the specific experience.

• 2 years of experience in a GMP Quality Assurance operational role mainly in the production oversight of pharmaceuticals biologics and/or cell/gene therapies.

Quality Assurance Engineer I:

• A bachelors degree in a Biological Sciences discipline Engineering or a related field. Substitution: A combination of education or related technical/paraprofessional experience may be substituted for the bachelors degree on a year for year basis.

• 4 years combined experience in GMP Manufacturing QA R&D in pharmaceutical biologics device or analytical testing environment (FDA regulated).

• 2 years of experience as part of the GMP Quality Assurance team

*Experience at this level can be gained simultaneously.

Applicants for all levels must meet minimum qualifications at the time of hire.

Preferred Qualifications:

• A masters degree in scientific discipline Biological Sciences or a related field.

• Experience working with Good Manufacturing Practices (GMPs) in regard to manufacturing operations and compliance with 21 CFR 210 and/or FACT regulations.

• 1 year or experience with IND generation and review; specifically CMC Module 3

• 5 years combined experience in GMP Manufacturing QA R&D in pharmaceutical biologics devices or analytical testing environment (FDA regulated industry).

• Prior experience working with Quality Management System such as Title21 Track wise Q-Pulse/IQM or Master control.

Competencies: Knowledge Skills and Abilities:

• Knowledge of FDA cGMP regulations FACT standards and GMP documentation practices.

• Ability to communicate effectively both in writing and orally. Strong English verbal and written communication skills required. Ability to accurately read interpret and produce technical documentation.

• Ability to establish and maintain effective working relationships with employees at all levels throughout the institution.

• Outstanding customer service skills.

• Highly self-motivated and organized with the ability to work both independently and collaboratively in a fast-paced team-oriented environment.

• Technical writing ability to draft and edit controlled documents such as SOPs Work Instructions (WIs) and forms.

Conditions of Employment:

• Applicants must be legally authorized to work in the United States without requiring sponsorship. We are unable to provide work visa sponsorship or employment authorization for this position now or in the future.

• Strong English verbal and written communication skills required with the ability to accurately read interpret and produce technical documentation.

• This position may require weekend work and work outside of normal work hours to accommodate the completion of release testing or other critical processes which cross shifts. While not typical this irregularity of work hours should be expected.

How to Apply:

For full consideration please submit the following document(s):

1. A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position

2. Curriculum vitae / Resume

3. Three to five professional references including name address phone number (mobile number if appropriate) and email address

Questions should be directed to: Chris Freedman

Screening of Applications Begins:

Screening begins on October 9 2026.

Anticipated Pay Range:

The starting salary range (or hiring range) for this position has been established as:

• QA Assoc II: $63443 - $85013

• QA Engineer I: $75000- $90000

The above salary range (or hiring range) represents the Universitys good faith and reasonable estimate of the range of possible compensation at the time of posting. This position may be eligible for overtime compensation depending on the level.

Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave health plans and retirement contributions that add to your bottom line.

Total Compensation Calculator

Equal Employment Opportunity Statement:

CU is an Equal Opportunity Employer and complies with all applicable federal state and local laws governing nondiscrimination in employment. We are committed to creating a workplace where all individuals are treated with respect and dignity and we encourage individuals from all backgrounds to apply including protected veterans and individuals with disabilities.

ADA Statement:

The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act please contact the Human Resources ADA Coordinator at .

Background Check Statement:

The University of Colorado Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty staff students and visitors. To assist in achieving that goal we conduct background investigations for all prospective employees.

Vaccination Statement:

CU Anschutz strongly encourages vaccination against the COVID-19 virus and othervaccine preventable diseases. If you work visit or volunteer in healthcare facilities or clinics operated by our affiliated hospital or clinical partners or by CU Anschutz you will be required to comply with the vaccination and medical surveillance policies of the facilities or clinics where you work visit or volunteer addition if you work in certain research areas or perform certain safety sensitive job duties you must enroll in theoccupational health medical surveillance program.