Quality Assurance Monitor in Audubon Bioscience

Direct message from Audubon Bioscience to the job posting member Tetiana Serhiyenko Tetiana Serhiyenko Human Resource Specialist HR Management Talent Management | Stand with Ukraine 💙💛 Audubon Bioscience (https://audubonbio.com) - is an innovative Biobank operating to support cutting-edge biomedical research in order to find new effective methods of Cancer diagnostics and treatment. The mission of the company is to provide biosamples, their clinical data , lab tests and other related services to scientists who work on research and development of new diagnostics and treatments in the field of Precision Medicine, primarily Cancer Research, in order to support scientifically and ethically sound biomedical research and contribute to the better health and well-being of people throughout the world. Audubon Bioscience through affiliated companies in 10 countries partners with a wide network of 100+ clinics globally (USA, Europe, Asia, Africa). The headquarters of the company is located in Houston, Texas. We open a vacancy of: Quality Assurance Monitor (full-time, Kyiv Office) The goal of the role is to conduct on-site visits to the collection sites, monitor project documentation, and collection processes, and analyze and report the results in a defined frequency., ensuring the correctness of the filled information and adherence to regulatory requirements, company standards, and best practices in biobanking Job Duties: Inspect ICFs, CRFs and other study documents for completeness and correctness as to original medical records. Review QC outcomes and resolve issues if possible, if not, appropriately escalate the issues to management Work with Audubon Quality team to investigate and complete non-conforming events Conduct routine and ad hoc visits to collection sites to ensure processes comply with regulatory standards, company policies, and protocols. Perform thorough inspections and quality assessments of on-site processes, including data collection, patient safety protocols, and adherence to Good Clinical Practice (GCP) guidelines. Collaborate with collection site staff to identify and address any quality issues, and provide guidance and recommendations for process improvements. Verify that collection site documentation is complete, accurate, and aligned with study requirements, including regulatory submissions and patient consent records. Review and assess adherence to training requirements and qualifications for on- site personnel involved in sample collection. Prepare detailed reports summarizing visit findings, quality observations, and compliance issues, and present recommendations to Audubon Quality and Operations teams. Support risk management processes by identifying and escalating potential compliance risks or quality issues.Act as a liaison between the collection site and country headquarters to facilitate efficient communication and resolution of quality concerns.Contribute to continuous improvement initiatives and provide input on quality-related policies and procedures.Stay updated on industry best practices, changes in regulations, and advancements in quality monitoring methodologies.Requirements:Bachelor’s degree in life sciences, healthcare, biotech or a related field.2+ years of experience in quality audits and inspectionsFamiliar with biobank servicesAbility to travel frequently and adapt to varied on-site conditions.Knowledge of regulatory requirements, and GCP guidelinesDetail-oriented with strong analytical and observational skills.Excellent communication and interpersonal abilities for effective collaboration with collection site staff and internal teams.Strong verbal and written communication skills  The company offers:Full-time position in a fastly growing business of biotechnologyExcellent professional and career opportunitiesOpen-minded executive managementFriendly and supportive teamIntellectually stimulating training from the best providers in the biobanking field Fully paid vacation and sick leaveAudubon Bioscience is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, creed, color, religion, alienage or national origin, ancestry, citizenship status, age, pregnancy, disability, sex, marital status, veteran status, sexual orientation, genetic information, arrest record, gender identity, or any other characteristic protected by applicable federal, state or local laws. Show more Show less Посадовий рівень Базовий рівень Тип зайнятості Повний робочий день Галузі Дослідницькі послуги