Junior Quality Assurance Specialist

Job Summary:

The Junior Quality Assurance Specialist is a position within Exsera Biolabs, which is a laboratory with unique and internationally recognized expertise in Complement Immunobiology.  Exsera BioLabs is a niche laboratory that is on a grow trajectory.  Exsera provids testing to support patient diagnostics, biomarker translation and working with clinical researchers, biotech, and pharmaceutical companies to help advance their scientific discoveries and drug development goals, especially in esoteric and standard complement testing, but also offerings in the areas of autoimmunity, immune-inflammation, and translational biomarkers. 

This position provides an opportunity to participate directly in industry and academic efforts to advance science and new drug development. 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 Junior Quality Assurance Specialist 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. 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:

• Perform scientifically rigorous data management and data integrity review.
• Develop and disseminate a variety of tools designed to facilitate review of data integrity and quality.
• 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.
• Gain and maintain knowledge on current industry standards for QA auditing of clinical and non-clinical trials data.

Work Location:

Hybrid – this role is eligible for a hybrid schedule (once fully trained) of 1-2 days per week on campus and as needed for in-person meetings. Fully remote positions may be possible for more experienced individuals. 

Why Join Us:

We are a tight-knit team with a lot of experience in clinical diagnostic laboratory research. Our team has expanded a lot in the last few years, which has allowed for new and exciting opportunities for growth, and the opening of new positions. Being a part of Exsera BioLabs allows you to be included in a great team involved in areas of complement and autoimmune testing research.  This lab brings together a wide range of expertise from project managers, biospecimen testing and diagnostics, QA expertise and is a leading lab in complement research and testing.

The University of Colorado offers a comprehensive benefits package that includes health insurance, life insurance, retirement plans, tuition benefits, ECO pass, paid time off – vacation, sick, holidays and more. To see what benefits are available, please visit: https://www.cu.edu/employee-services/benefits-wellness .

Diversity and Equity:

The University of Colorado Anschutz Medical Campus is committed to recruiting and supporting a diverse student body, faculty, and administrative staff. The university strives to promote a culture of inclusiveness, respect, communication and understanding. We encourage applications from women, ethnic minorities, persons with disabilities, persons within the LGBTQ+ community and all veterans. The University of Colorado is committed to diversity and equality in education and employment.

Qualifications:

Minimum Qualifications:

• Bachelor’s degree in Bioinformatics, Biostatistics, Computational Biology, Data Science, Computer Science, Biology, or related field.
  • A combination of education and related technical/paraprofessional experience may be substituted for the bachelor’s degree on a year for year basis.

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 or data review.
• Previous experience with clinical trials or clinical studies.
• Previous experience with regulated laboratory testing.
• Previous experience with quality assurance or quality management.
• Previous experience with data review.

Knowledge, Skills, and Abilities:

• Strong knowledge of basic statistical principles, and importance of data relevant in medical research.
• Ability to analyze and solve complex problems and apply quantitative analytical approaches.
• 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.
• Demonstrated commitment and leadership ability to advance diversity and inclusion.
• Knowledge of basic human anatomy, physiology, and medical terminology.
• Ability to interpret and master complex research protocol information.
• Knowledge of regulatory data requirements.
• Ability to handle multiple projects concurrently, with flexibility regarding priorities, and meeting assigned deadlines.
• Ability to work independently and productively; self-motivated to produce quality work with minimal direction.
• Detail-oriented with the ability to exercise initiative and sound judgment.
• Ability to adapt to a variety of responsibilities, work assignments, and priorities.
• Commitment to advancing patient care and drug development.
• Aptitude for finding answers and detecting errors.

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 Lacey-Severa, [email protected]  

Screening of Applications Begins:

Immediately and continues until March 12th , 2024.

Anticipated Pay Range:

The starting salary range (or hiring range ) for this position has been established as $50,112 – $63,742.

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: http://www.cu.edu/node/153125

ADA Statement:

The University will provide reasonable accommodation 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 [email protected] ​.

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 .