Quality Assurance Monitor

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 inspections
• Familiar with biobank services
• Ability to travel frequently and adapt to varied on-site conditions.
• Knowledge of regulatory requirements, and GCP guidelines
• Detail-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 biotechnology
• Excellent professional and career opportunities
• Open-minded executive management
• Friendly and supportive team
• Intellectually stimulating training from the best providers in the biobanking field 
• Fully paid vacation and sick leave
• Medical insurance after probation period