Open Rank Quality Assurance Specialist (Entry - Senior)

Job Summary:

This position involves the reviewing of data related to patient diagnostic testing under CAP and CLIA regulations, as well as work under the FDA GxPs as involved in new drug development, working largely independently with personal accountability and responsibilities. The individual will need to exercise discretion and analytical skills to investigate and disentangle complicated data processes. This Senior Information Science Professional will utilize applied or computational mathematical analyses for a wide array of different applications with a particular focus on the validation and assurance of quality data. The position will be part of a team doing esoteric and niche testing in complement and autoimmunity. As a member of the Exsera BioLabs Quality Assurance group the candidate will need to be detail-oriented and have a strong interest in advancing human health. After training is complete, a hybrid on campus and work from home schedule may be optimal.

Key Responsibilities:

• Work independently but in coordination with the current Quality Assurance team.

• Be part of ensuring quality patient care through work to ensure the accuracy and completeness of clinical trials pharmacodynamic data.

• Assist with data review for a clinical trial.

• Conduct full reviews of data and reports for adherence to the laboratory SOPs and the study protocol.

• Perform accuracy reviews for tabulation of data prior to release to client.

• Assist QA Team in phase inspections and facility inspections.

• Participate in hosting client audits and inspections and participate in visit and inspections.

• Aid in the updating and preparation of laboratory standard operating procedures and controlled documents.

• Participate in CAPA investigations and improvement activities.

• Maintain detailed records of studies to ensure compliance with requirements of the Food and Drug Administration (FDA).

• Independently master study materials, including but not limited to protocols and all other essential study documents for assigned studies.

• Independently perform study quality assurance related processes, procedures, and assessments as defined in study protocol and in compliance with regulating bodies.

• Assist Senior Quality Assurance staff on multiple trials/studies.

Work Location:

Hybrid - this role is eligible for a hybrid schedule of 1 day per week on campus and as needed for in-person meetings and client audits/inspections.

Why Join Us:

Exsera BioLabs is part of the Colorado School of Medicine on the Anschutz medical campus, a health care focused scientific environment that offers countless opportunities for growth, both personal and professional. Exsera is a growing laboratory in the forefront of rheumatology and complement immunolobiology. We are a large laboratory with ample opportunities for growth and with ample support in the role. As our laboratory is a clinical immunology laboratory, we have the privilege of helping patients and their families find answers and in concert with our study sponsors, new treatments for the rare diseases; which makes for rewarding work.

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:

Entry Level:

• Bachelor's degree in Bioinformatics, Biostatistics, Computational Biology, Data Science, Computer Science or related field

Intermediate Level:

• Bachelor's degree in Bioinformatics, Biostatistics, Computational Biology, Data Science, Computer Science or related field.

• One (1) year of data management and bioinformatic analyses experience.

Senior Level:

• Bachelor's degree in Bioinformatics, Biostatistics, Computational Biology, Data Science, Computer Science or related field.

• Two (2) years of data management and bioinformatic analyses experience.

  • A combination of education and related technical/military/paraprofessional experience may be substituted for a bachelor's degree on a year for year basis.

An advanced degree (Masters or Doctorate) may be substituted for experience on a year for year basis if the degree is in a field of study directly related to the work assignment.

Applicants must meet minimum qualifications at the time of hire.

Preferred Qualifications:

• Master's degree in Bioinformatics, Biostatistics, Computational Biology, Data Science, Computer Science or related field.

• One (1) year of experience analyzing data using high-performance computing

• Previous experience in one or more of the following areas:

  • Clinical trials or Clinical studies

  • Regulated laboratory testing

  • Quality Assurance or Quality Management

  • Data review

• One (1) or more years of data review at a quality assurance level.

• One (1) or more years of quality assurance data experience.

• One (1) or more years of experience in a regulated laboratory environment.

Knowledge, Skills and Abilities:

• Strong knowledge of basic statistical principles relevant in medical research.

• Ability to analyze and solve complex problems and apply quantitative analytical approaches.

• Demonstrated fluency in one or more programming languages (e.g., R, Python, Perl, Java, C++) and willingness to learn new programming languages as necessary.

• Familiarity with statistical analytical concepts and methods.

• Ability to communicate effectively, both in writing and orally.

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

• Outstanding customer service skills.

• Knowledge of basic human anatomy, physiology, and medical terminology.

• Ability to interpret and master complex research protocol information.

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.

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: Paige Lacy-Severa, Paige.Lacy-Severa@cuanschutz.edu

Screening of Applications Begins:

Immediately and continues until position is filled. For best consideration, apply by 6/10/26

Anticipated Pay Range:

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

• Entry Level: $53,631 - $71,866

• Intermediate Level: $58,363 - $78,207

• Senior Level: $63,096 - $84,548

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.