Quality Control Associate II

Job Summary:

This position is a full-time, intermediate-level position at the Gates Biomanufacturing Facility located on the Anschutz Medical Campus and serves on the Quality Control team. With varying degrees of independence, this position performs routine analytical testing in a multidisciplinary laboratory space in support of analytical development, qualification, and release testing of protein biologics and regenerative medicine cellular therapies. This position will be required to understand and implement aseptic technique in the laboratory and GMP clean suites.

This position will be expected to perform beginner-level tasks such as low complexity analytical procedures and the drafting or editing of related documentation. This position will begin establishing their knowledge base regarding the analytical methodology that they are routinely performing as well as basic Quality principles such as Good Documentation Practices (GDP) as well as Good Manufacturing Practices (GMP). All work will be completed within a GMP (21 CFR Part 210/211) Quality Control laboratory. This position may support method development. This position will NOT support any academic research.

Key Responsibilities:

• Generate, submit, and analyze environmental monitoring samples from the GMP manufacturing clean suites on a weekly basis.
• Generate, submit, and analyze utilities monitoring samples from the facility on a routine basis.
• Perform protein biologic analytical tests to support cGMP batch release (Conductivity, DLS, ELISA, pH, SDS-PAGE, TOC, and UV-Vis spectrophotometry).
• Perform microbiological analytical tests to support cGMP batch release (Bioburden, Endotoxin, Gram Stain, and Mycoplasma).
• Perform regenerative medicine cellular therapy analytical tests to support cGMP batch release (Thawing and Cell Counting).
• Participate in the resolution and investigations associated with Non-conformance processes (OOS, OOT, CAPA, and deviations).
• Refine and implement key laboratory and analytical SOPs in the QC lab.

Work Location:

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

Why Join Us:

The opportunity offered by the Gates Institute is one of a kind. We blend the best of a large research organization of over 40,000 employees strong, with the family atmosphere of working with a team of 50+ highly dedicated people, operating on a top tier research campus - the University of Colorado - Anschutz Medical Campus.

The Gates Institute and its partners on the CU Anschutz Medical Campus are delivering lifesaving therapies and working to develop more every day. We are only limited by our resources and need you to make our journey a success!

In addition to the benefits offered, a few links are included below, identifying some of the exciting life sciences the Gates Institute is delivering to patients.

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, and holidays and more. To see what benefits are available, please visit: https://www.cu.edu/employee-services/benefits-wellness.

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: 10/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.

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, ethnically minoritized individuals, persons with disabilities, persons within the LGBTQ+ community and all veterans. In addition, the Anschutz Campus has also been recognized as an Age-Friendly University. The University of Colorado is committed to diversity and equality in education and employment.

Qualifications:

Minimum Qualifications:

• A bachelor's degree in related life science discipline or equivalent experience or a directly related field from an accredited institution.
• 1+ years of Quality Control experience in a cGMP laboratory setting.

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 the minimum qualifications at the time of hire.

Condition of Employment:

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.

Applicants must meet minimum qualifications at the time of hire.

Preferred Qualifications:

• 2+ years of Quality Control experience in a cGMP laboratory setting.
• Experience with performing HPLC analyses on Agilent hardware and ChemStation software.
• Experience with HPLC analytical method development.
• Experience working with 21 CFR 58, 210, 211, 600 and 1271.
• Experience working in a pharma/biotech startup environment.
• Quality system building experience

Knowledge, Skills and Abilities:

• 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.
• Capable of working as an individual or in a team setting.
• Motivated self-starter capable of operating in a start-up environment.

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: Donna.3.Parker@cuanschutz.edu

Screening of Applications Begins:

Immediately and continues until position is filled. For best consideration, apply by November 18, 2024

Anticipated Pay Range:

The starting salary range (or hiring range) for this position has been established as $48,119 - 61,208.

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 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.