Quality Assurance Consultant

Alphanumeric•Chicago, IL

8d•Onsite

About The Position

Alphanumeric is hiring a QUALITY ASSURANCE CONSULTANT to work part-time in the Chicago, IL area. This position will 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).

Requirements

5+ years of Quality Assurance experience in regulated environments spanning biobanks/biorepositories and clinical laboratories (academic, commercial, or translational settings).
Hands-on participation in FDA inspections, sponsor audits, and/or accreditation audits (e.g., 21 CFR Parts 58, 312; CLIA/CAP as applicable), including front-room/back-room coordination, evidence management, and inspection response support.
Direct auditing of biobank operations, including informed consent and IRB documentation, sample accessioning, storage and retrieval, LN₂ and ultra-cold chain handling, inventory control, chain of custody, and sample release.
Direct auditing of clinical laboratory operations, including method validation/verification, equipment qualification, reagent and material control, data review practices, and sample handling through testing and reporting.
Working knowledge of risk-based Quality Management Systems, GxP principles (GLP/GCP with GMP awareness), and data integrity frameworks (ALCOA/ALCOA+).
Experience supporting and overseeing computerized systems relevant to biobank and clinical lab operations, including LIMS, freezer/environmental monitoring systems, and laboratory data interfaces; exposure to CSV concepts preferred.
Strong capability in SOP lifecycle management, deviations, CAPA development and effectiveness, change control, training programs, and quality metrics.
Familiarity with CLIA/CAP requirements for clinical testing and HIPAA/GDPR touchpoints related to donor/sample data, PHI, and privacy.
Proven ability to author clear, risk-based audit reports and remediation plans, including Critical/Major/Minor classifications and practical timelines.
Calm, confident presence during inspections and audits, with strong front-room communication and back-room evidence coordination.
Collaborative, hands-on consultant mindset-able to translate regulatory expectations into practical, workflow-aligned solutions.
Coaching-oriented approach that builds operational confidence and sustainable compliance culture.
Reliable on-site contributor Monday-Thursday, able to integrate quickly with laboratory, biobank, IT, and QA stakeholders.