Quality Assurance Consultant

Quality Assurance Consultant

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).

• 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.

Mid‑Senior level

Part‑time

Quality Assurance

Pharmaceutical Manufacturing