Quality Assurance Consultant

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).

• 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

Alphanumeric is a dynamic company born of a diverse mindset and held to a distinctly high standard. You may know us as a tech and communications firm established in 1979, but we also lead life science and healthcare organizations toward a more efficient future across the globe, bringing patients and providers together to build personalized relationships that fit their needs.But at our core, we are a family with a shared and passionate dedication to our customers. We treat our candidates as amazing (because they are!)Apply today to join our family and Make Your Mark!