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University of Colorado l Anschutz Medical CampusSchool of Medicine, Department of Medicine, Division of Allergy and Clinical ImmunologySenior Regulatory/Quality Assurance Coordinator (Business Services Senior Professional)Position #767214 – Requisition 17302
The University of Colorado Denver l Anschutz Medical Campus seeks individuals with demonstrated commitment to creating an inclusive learning and working environment. We value the ability to engage effectively with students, faculty and staff of diverse backgrounds.The Division of Allergy and Clinical Immunology has an opening for a full-time, University Staff (unclassified) Senior Regulatory/Quality Assurance Coordinator (Business Services Senior Professional) position.The University of Colorado Anschutz Medical Campus ranks among the top institutions nationally in clinical care, education and research. Its 230-acre campus, designed to enhance collaboration and interprofessional education, hosts the College of Nursing; the Schools of Dental Medicine, Medicine, Pharmacy, and Public Health; the Graduate School; a Health Sciences Library; and two hospitals. Strategically located contiguous to the campus are a biosciences research park and the soon-to-be-completed Veterans Hospital. CU Anschutz offers two undergraduate degrees, 35 graduate degrees, and five first-professional programs. More than 4,000 students learn alongside faculty members who also make meaningful medical discoveries and provide expert clinical care through 1.5 million patient-visits annually. A hub for research and innovation, CU Anschutz receives over $400 million in research awards each year and has filed 1,300 patent applications and formed 53 new companies since 2002. Read CU Anschutz Quick Facts here.Nature of Work:Jobs in this career family provide general business operations of the organization or a combination of operational responsibilities covering multiple career families. Functions include institutional research, statistical analysis, policy development and review, strategic planning and broad unit business operations such as parking and transportation services, risk management, childcare services, real estate and property management, retail services or job responsibilities that combine fiscal, HR and operational management responsibilities.Senior Professionals are responsible for exercising discretion, analytical skill, personal accountability and responsibility in a wide range of areas including academic, administrative, managerial and student services functions. Work involves creating, integrating, applying and sharing knowledge directly related to a professional field. Work is performed fully independently.The Senior Regulatory/Quality Coordinator is responsible for providing high level support to the Quality Manager and Director of Regulatory Affairs with regard to the ClinImmune Labs -Histocompatibiity, Cord Blood Bank and Stem Cell Laboratory compliance with regulatory agencies and accrediting organizations, including FDA, CLIA, ASHI, FACT, AABB, IRB and CAP, along with implementing ClinImmune Labs’ Quality Assurance Program.Examples of Work Performed:
Regulatory Responsibilities:
Interact closely with ClinImmune staff, faculty, stakeholders, and other University personnel to ensure that SOPs and proper documentation are prepared and implemented for processes and studies that meet applicable regulatory standards.
Prepare regulatory documents in paper and electronic format to maintain quality assurance consistent with FDA, FACT, AABB, CAP, ASHI and other appropriate regulations.
Manage day-to-day regulatory activities and provide regulatory support and guidance through participation in study/project team meetings.
Manage regulatory files in ClinImmune’s Quality Unit, ensuring that all records meet GCP, FDA, other regulatory agencies, and company policies.
Develop and maintain regulatory policies and procedures (Standard Operating Procedures, Protocol-Specific Procedures, training manuals, etc.).
Maintain current regulations and guidance documents by attending meetings, seminars, and conferences on relevant topics, and by reading scientific literature.
Work within a team setting to meet timelines and objectives.
Quality Assurance Responsibilities:
Implement QA program in accordance with company policy.
Manage QA activities related to regulatory submissions, including document approval and release.
Ensure that other personnel involved in QA activities are qualified and trained as needed to perform required functions.
Manage internal Quality Assurance audits according to the Quality Manual and relevant SOPs.
Survey regulatory agencies and other materials for changes in guidelines that relate to QA activities; maintain current regulations and guidance documents by attending meetings, seminars, and conferences on relevant topics, and by reading the scientific literature.
Strive for continual improvement of QA processes, activities, and results.
This description is a summary only and is describing the general level of work being performed, it is not intended to be all-inclusive. The duties of this position may change from time to time and/or based on business need. We reserve the right to add or delete duties and responsibilities at the discretion of the supervisor and/or hiring authority.PLEASENOTE:Candidates will be responsible for travel expenses related to the interview process and any relocation expenses, if applicable
Salary and Benefits:The hiring salary for this position is commensurate with skills and experience. This position is not eligible for overtime compensation.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.Benefits:https://www.cu.edu/employee-services/benefits.Total Compensation Calculator:https://www.cu.edu/employee-services/total-compensationMinimum Qualifications:
A bachelor’s degree in medical technology, science, business, business administration, finance, accounting, healthcare administration, public administration, communications, information systems, or a directly related field from an accredited institution.
Two (2) years of professional level experience ensuring regulatory compliance or quality assurance within a scientific or research setting.
Substitution: A combination of education and related technical/paraprofessional experience may be substituted for the bachelor’s degree on a year for year basis, but not for the specific experience.Preferred Qualifications:
3-5 years of Regulatory and/or Quality experience.
Experience with FDA registration and licensure, AABB, ASHI, CAP, or FACT.
Competencies/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.
Ability to manage multiple projects and competing deadlines
Training and/or thorough and practical understanding of QA principles and practices.
Diversity and Equity:Please click here for information on disability accommodations:http://www.ucdenver.edu/about/departments/HR/jobs/Pages/JobsatCUDenver.aspxThe University of Colorado Denver | 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 and all veterans. The University of Colorado is committed to diversity and equality in education and employment.The University of Colorado Denver | 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.Job: Business ServicesOrganization: U0001 DENVER & ANSCHUTZ MED CAMPUSTitle: Senior Regulatory/Quality Assurance CoordinatorLocation: AuroraRequisition ID: 17302
