Job Summary:

This is a full time (100% FTE), University Staff (non-classified) Quality Assurance Coordinator position available at ClinImmune Cell & Gene Therapy within the Division of Allergy and Clinical Immunology at the University of Colorado Anschutz Medical Campus. ClinImmune provides umbilical cord blood and tissue banking, clinical testing for human stem cell and organ transplants, stem cell product processing and infusion services, and histocompatibility and immunogenetics testing for human stem cell & organ transplantation. ClinImmune is also very involved with gene therapy research and development and flow cytometric testing. This position is responsible for supporting high level quality and regulatory operations, including research support to the ClinImmune faculty and staff in the areas of training, quality improvement/control, process development and regulatory compliance.

Key Responsibilities:

• Participate in audit process for both internal and external entities, including the design and performance of internal audits, scheduling, coordinating, and providing resolution for deficiencies. Summarize and present audit results at quality review meetings.
• Maintain document control system, including "Master" and "Archived" files. In addition, review the staff training, annual continuing education requirements, competency, and SOP Reviews.
• Review master batch records, coordinate medical director review of product files, and approve cell therapy products for infusion.
• Review, complete, and submit accreditation application documentation for appropriate regulatory agencies, including FDA (GMP and GTP), ASHI, CAP, AABB, AATB, and FACT. Approve and submit annual documentation of facility accreditation. Must maintain knowledge of current standards, work independently, and with quality manager, to educate and train staff on compliance with all standards.
• Assess updates to FDA regulations on human cells, tissues, and cellular and tissue-based product (HCT/Ps).
• Perform quality assessment and review of occurrences (CAPA). Utilize various recording and tracking systems (such as internal databases) to analyze events and determine appropriate resolution with guidance of management. Verify effectiveness of any corrective and preventative actions. Determine when an occurrence needs to be reported to the FDA as 3500a or 3486 BPDR.
• Independently master study materials, including but not limited to protocols, informed consent forms, and all other essential study documents for assigned studies that ClinImmune has taken on to assist clinical trials being performed by other University departments or is performing themselves.
• Organize and review quality systems including document control, internal and external audits, validations and verifications, IRB applications and continuing review, CAPA documentation and resolution, proficiency testing, and quality improvement.

Work Location:

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

Why Join Us:

As an academic based biotechnology company, ClinImmune Cell & Gene Therapy is committed to providing the highest quality service and support to clinical customers and researchers locally and abroad. Our prime location at the University of Colorado Anschutz Medical Campus allows for collaboration with world-renowned clinicians and scientists. ClinImmune Cell & Gene Therapy is an academic and clinical component of the University of Colorado Anschutz Medical Campus.

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:

Entry Level:

• A bachelor's degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, finance, accounting, business administration, business, or a directly related field from an accredited institution.
  • A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis.

Intermediate Level:

• A bachelor's degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, finance, accounting, business administration, business, or a directly related field from an accredited institution.
  • A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis.
• One (1) year of professional level experience in a Quality Assurance position.

Senior Level:

• A bachelor's degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, finance, accounting, business administration, business, or a directly related field from an accredited institution.
  • A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis.
• Two (2) years of professional level experience in a Quality Assurance position.

Applicants must meet minimum qualifications at the time of hire.

Preferred Qualifications:

• One (1) to three (3) years of clinical research or related experience.
• Laboratory certification ABHI and/or ASCP (MT or SBB).
• Experience with software validations.
• Quality Certification.
• One (1) year of experience in HLA testing.

Knowledge, Skills, and Abilities:

• Knowledge and understanding of federal regulations on biologics including GTP, GMP, BLA, and IND.
• Knowledge and understanding of accrediting agency standards.
• 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 medical terminology.
• Ability to interpret and master complex protocols and guidance.
• Proficient with Microsoft Excel, Word, and PowerPoint.
• Familiarity with electronic document control and quality management systems.

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: Timothy Lovato, timothy.lovato@cuanschutz.edu

Screening of Applications Begins:

Applications will be accepted until finalists are identified, but preference will be given to complete applications received by May 31^st, 2024. Those who do not apply by this date may or may not be considered.

Anticipated Pay Range:

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

Entry Level: $50,996 - $64,867

Intermediate Level: $55,496 - $70,590

Senior Level: $59,996 - $76,314

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.