Open Rank Quality Assurance Specialist (Entry Senior)

University of Colorado Anschutz Medical Campus

Department: Medicine - Division of Rheumatology Position #: 00849208 - Requisition #: 40133

Job Summary

This position involves reviewing data related to patient diagnostic testing under CAP and CLIA regulations, as well as work under FDA GxPs for new drug development. You will work largely independently with personal accountability to investigate and disentangle complicated data processes. As a member of the Exsera BioLabs Quality Assurance group, you will utilize applied or computational mathematical analyses with a focus on the validation and assurance of quality data.

Key Responsibilities

• Work independently and in coordination with the Quality Assurance team to ensure accurate and complete clinical trial pharmacodynamic data.
• Conduct full reviews of data and reports for adherence to laboratory SOPs and study protocols.
• Perform accuracy reviews for data tabulation prior to client release.
• Assist the QA team in phase and facility inspections, including hosting client audits.
• Aid in updating and preparing laboratory standard operating procedures and controlled documents.
• Participate in CAPA investigations and improvement activities.
• Maintain detailed records to ensure compliance with FDA requirements.
• Independently master study materials, protocols, and essential documents.
• Assist Senior Quality Assurance staff on multiple trials and studies.

Work Location

Hybrid (eligible for 1 day per week on campus, with additional in-person requirements for meetings and audits).

Why Join Us

• Comprehensive medical, dental, vision, disability, and life insurance.
• Retirement 401(a) Plan: Employer contributes 10% of gross pay.
• Generous Paid Time Off: 22 vacation days, 15 sick days, and 15 holidays per year.
• Tuition benefit for CU campuses.
• Reduced rate RTD Bus and light rail service (ECO Pass).

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 a related field plus one (1) year of data management and bioinformatic analysis experience.
• Senior Level: Bachelor's degree in a related field plus two (2) years of data management and bioinformatic analysis experience.

Preferred Qualifications

• Master's degree in a related field.
• One (1) year of experience analyzing data using high-performance computing.
• Experience in clinical trials, regulated laboratory testing, or Quality Assurance/Management.

Anticipated Pay Range

• Entry Level: $53,631 - $71,866
• Intermediate Level: $58,363 - $78,207
• Senior Level: $63,096 - $84,548

How to Apply

Please submit:

1. A letter of interest describing relevant experience.
2. Curriculum vitae / Resume.
3. Three to five professional references.

Apply via the official University of Colorado portal: https://cu.taleo.net/careersection/2/jobdetail.ftl?job=40133&lang=en