Quality Assurance Coordinator (Entry – Senior Level) - 33462 University Staff

Description

University of Colorado Anschutz Medical Campus

School of Medicine | Department of Medicine | Division of Allergy & Clinical Immunology | ClinImmune Cell & Gene Therapy

Job Title: Quality Assurance Coordinator (Entry – Senior Level)

Position #00821741 – Requisition #33462

Job Summary:

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

Why Join Us:

Diversity and Equity:

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:

Screening of Applications Begins:

May 31 st , 2024

Anticipated Pay Range:

or hiring range

Entry Level:

Intermediate Level:

Senior Level:

or hiring range

ADA Statement:

Background Check Statement:

Vaccination Statement:

Qualifications

Job Category

Primary Location

Schedule

Posting Date

Unposting Date

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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.

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

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 (https://apptrkr.com/get_redirect.php?id=5230445&targetURL=https://www.cu.edu/employee-services/benefits-wellness) .

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.

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 (https://apptrkr.com/get_redirect.php?id=5230445&targetURL=timothy.lovato@cuanschutz.edu)

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

The starting salary range () for this position has been established as: $50,996 - $64,867 $55,496 - $70,590 $59,996 - $76,314 The above salary 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 (https://apptrkr.com/get_redirect.php?id=5230445&targetURL=http://www.cu.edu/node/153125)

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 (https://apptrkr.com/get_redirect.php?id=5230445&targetURL=hr.adacoordinator@cuanschutz.edu) ​.

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.

CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine preventable diseases (https://apptrkr.com/get_redirect.php?id=5230445&targetURL=https://www.cdc.gov/vaccines/schedules/downloads/adult/adult-combined-schedule.pdf) . 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 (https://apptrkr.com/get_redirect.php?id=5230445&targetURL=https://research.cuanschutz.edu/ehs/home/divisions/occupational-health/oh-enrollment) .

Application Materials Required: Cover Letter, Resume/CV, List of References : Research Services : Aurora Department: U0001 -- Anschutz Med Campus or Denver - 20174 - SOM-MED-Clinical Immunology : Full-time : May 2, 2024 : Ongoing Posting Contact Name: Timothy Lovato Posting Contact Email: timothy.lovato@cuanschutz.edu (https://apptrkr.com/get_redirect.php?id=5230445&targetURL=timothy.lovato@cuanschutz.edu) Position Number: 00821741jeid-fa13c0c612fdaf43b9d8b48d34a2b753

The University of Colorado does not discriminate on the basis of race, color, national origin, sex, age, pregnancy, disability, creed, religion, sexual orientation, gender identity, gender expression, veteran status, political affiliation, or political philosophy. All qualified individuals are encouraged to apply.