Quality Assurance Consultant at Alphanumeric Systems Inc. Chicago, IL

Position Overview Part-time Quality Assurance Consultant to support integrated biobank and clinical laboratory operations within a regulated life sciences environment. The consultant will strengthen quality systems, inspection readiness, and day-to-day compliance across sample lifecycle management and clinical testing workflows, working closely with operations, IT, and leadership on-site in Chicago (Mon - Thu). Core Responsibilities Conduct comprehensive Gap Analyses to identify compliance gaps within biobank and clinical laboratory operations. Develop and implement Remediation Plans to address identified gaps, ensuring adherence to regulatory requirements. Lead FDA Inspection Readiness initiatives, providing on-site support during inspections, audits, and accreditation processes. Perform direct audits of biobank and clinical laboratory operations, ensuring compliance with informed consent processes, IRB documentation, sample handling, storage, and chain of custody. Evaluate laboratory practices related to method validation, equipment qualification, and data integrity, implementing necessary improvements. Manage the lifecycle of Standard Operating Procedures (SOPs), including development, revision, and effectiveness monitoring. Provide training to laboratory and biobank staff on compliance, operational best practices, and regulatory requirements. Author clear and actionable audit reports and remediation plans, prioritizing findings based on risk classifications. Serve as a collaborative partner with laboratory, biobank, IT, and QA teams, translating regulatory expectations into practical solutions. Qualifications Minimum of 5 years of Quality Assurance experience within regulated environments, specifically in biobanks/biorepositories and clinical laboratories. Proven hands-on experience in FDA inspections, sponsor audits, and accreditation audits, with a focus on 21 CFR Parts 58 and 312 and CLIA/CAP standards. Strong knowledge of risk-based Quality Management Systems, GxP principles, and data integrity frameworks (ALCOA/ALCOA+). Familiarity with computerized systems used in laboratory and biobank operations, including Laboratory Information Management Systems (LIMS) and environmental monitoring systems; exposure to Computerized System Validation (CSV) concepts is preferred. Familiarity with CLIA/CAP requirements for clinical testing and HIPAA touchpoints related to donor/sample data, PHI, and data privacy/protection. Excellent communication skills with a calm and confident demeanor during inspections and audits; adept in front-room and back-room coordination. Ability to build a sustainable compliance culture through hands-on coaching and continuous improvement mindset. Reliable on-site contributor, available Monday through Thursday, with the ability to collaborate quickly with cross-functional stakeholders. Preferred Attributes Coaching-oriented approach aimed at enhancing operational performance and building confidence among staff. Strong organizational skills with the ability to manage multiple projects and priorities effectively. Detail-oriented with a commitment to maintaining high standards of quality and compliance. Must be able to work W2 SR8308 #J-18808-Ljbffr Itlearn360