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 have AMAZING benefits and offer exceptional 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 bachelor's 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 bachelor's 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 bachelor's 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 bachelor's 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 master's 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,
211, 600, 1271, 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):
- A letter of interest describing relevant job experiences as
they relate to listed job qualifications and interest in the
position
- Curriculum vitae / Resume
- Three to five professional references, including name, address,
phone number (mobile number if appropriate), and email
address
Questions should be directed to: Chris Freedman,
christopher.freedman@cuanschutz.edu
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: $63,443 - $85,013
- QA Engineer I: $75,000 - $90,000
The above salary range (
or hiring range ) represents the
University's 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
hr.adacoordinator@cuanschutz.edu
.
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 other
vaccine 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, respectively. In addition, if you work in certain
research areas or perform certain safety sensitive job duties, you
must enroll in the
occupational health medical surveillance program .
