"Quality Assurance Coordinator (Entry Senior Level)"

Job Summary

The Quality Assurance Coordinator supports the mission, goals, and strategic plan of ClinImmune and the School of Medicine at the University of Colorado Anschutz Campus by performing monitoring, auditing, and overseeing the quality of clinical laboratory testing used to match organ donations with viable recipients. In addition, this position is responsible for the quality oversight of the stem cell processing services, transport, and cryopreservation of the product from the apheresis center, quality oversight of the performance of bedside thaw and infusion assistance in the hospital infusion center, and quality oversight of post-transplant surveillance of indicators of cell therapy product purity and potency.

This role will be responsible for reviewing clinical laboratory testing performed in the cell therapy and HLA labs, providing quality oversight, teaching the principles and requirements of quality assurance, thereby performing indirect patient care in assuring that all testing and cellular therapy products released by ClinImmune for use in patient transplant are of the highest quality. The Quality Assurance Coordinator is responsible for supporting the quality assurance functions of the organization by performing essential regulatory and quality management functions in compliance with, but not limited to, FDA regulations, CLIA regulations, AATB standards, FACT standards, AABB standards, CAP standards, ASHI standards, and internal policies and procedures.

At the Senior level, Quality Assurance Coordinators will operate independently and have a strong understanding of all relevant compliance, quality, and regulatory guidelines. These roles will act as key liaisons between ClinImmune, study sponsors and regulatory agencies in support of quality assurance, risk management, accreditation, and regulatory oversight.

Key Responsibilities

• Participates in regulatory submissions for Biological License Applications (BLA), filings, and communications with regulatory and accreditation agencies including audits including but not limited to the FDA, AABB, CAP, ASHI, FACT, and AATB and leads internal audits to ensure compliance.
• Oversees quality assurance in compliance with strict regulatory standards to make sure ClinImmune is delivering pure, and potent products for patient treatment and following proper laboratory protocols for patient sample testing and resulting. This requires laboratory oversight, and meeting regulatory agency requirements to ensure no harm can come to a patient.
• Reviews and assists with the preparation of occurrence (deviation) reports, complaints, and corrective and preventative actions (CAPA).
• Recognizes and reports trends and opportunities for improvement (OFI) through audits and occurrence reports to the Director of Regulatory Affairs and/or Quality Manager, which are then shared with ClinImmune management and staff.
• Reviews supplier qualifications, inventory quality control functions, change control functions, as well as developing and implementing risk mitigation strategies for regulatory and accreditation compliance.
• Reviews and assists with validation and verification proposals and summaries for equipment, software, and/or processes to ensure that all contain appropriate testing to show the subject of the validation is fit for use.
• Performs review of cell and gene therapy product files and sponsor protocols, ensuring accurate documentation, donor eligibility review for correct labeling of products and product safety, and that regulatory, accreditation, and quality processes are being followed for all cellular therapy products administered to University of Colorado Hospital patients, whether standard of care cellular therapy products or sponsored cellular therapy clinical trials.

Work Location

Hybrid - this role is eligible for a hybrid schedule of 2 days per week onsite and as needed for in-person meetings once deemed trained and competent.

Why Join Us

As an academic based biotechnology company, ClinImmune 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 is an academic and clinical component of the University of Colorado Anschutz Medical Campus.

Why work for the University? 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.

Qualifications

Minimum Qualifications

Entry Level: Bachelor's degree in biological sciences, chemistry, or clinical laboratory science. Other degree holders need not apply.
Intermediate Level: Bachelor's degree in biological sciences, chemistry, or clinical laboratory science. Other degree holders need not apply. One (1) year of professional health care or clinical quality assurance experience.
Senior Level: Bachelor's degree in biological sciences, chemistry, or clinical laboratory science. Other degree holders need not apply. Two (2) years of professional health care or clinical quality assurance experience.

Applicants must meet minimum qualifications at the time of hire.

Preferred Qualifications

• Experience with cell and gene therapies and HLA.
• Relevant, patient-focused biomedical experience (*equipment not included).
• Certification in quality management (e.g. ASQ or Six Sigma).
• Experience working with an electronic document control system.
• Direct healthcare-related experience.
• Two (2) - four (4) years of related quality assurance and regulatory affairs experience in a clinical laboratory.
• MT(ASCP) or MLS certification.

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 and active listening skills with the ability to recognize and take care of the patients' and clients' needs while following company procedures.
• Proficiency with Microsoft functions.
• Knowledge of human anatomy and medical terminology.
• Possess essential knowledge of the principles of clinical laboratory testing and quality control as it relates to HLA testing and cellular therapy product processing, labeling, storage, and preparation for infusion.
• Ability to be held accountable or answerable for one's work and conduct.
• Organization skills with the ability to complete work within given deadlines.
• Detail oriented with the ability to prioritize tasks accordingly and perform work accurately and thoroughly.
• Ability to work effectively with a team to work toward a goal.
• Ability to adapt to change in the workplace.
• Ability to follow established guidelines, policies, standards, or legislation.

Anticipated Pay Range

Entry Level: $56,555
Intermediate Level: $61,546
Senior Level: $66,536