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Alphanumeric Systems · 3 weeks ago

Quality Assurance Consultant

Chicago, IL

Part-time

Onsite

Senior Level

5+ years exp

Alphanumeric Systems 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, focusing on quality systems and compliance.

PharmaceuticalSoftware

H1B Sponsor Likely

Responsibilities

Support integrated biobank and clinical laboratory operations within a regulated life sciences environment

Strengthen quality systems, inspection readiness, and day-to-day compliance across sample lifecycle management and clinical testing workflows

Work closely with operations, IT, and leadership on-site in Chicago (Mon-Thu)

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

Qualification

Quality AssuranceFDA inspectionsBiobank operations auditingClinical laboratory auditingQuality Management SystemsLIMSSOP lifecycle managementCLIA/CAP requirementsAudit report writingCalm presenceCoaching-oriented approachReliable contributorCollaborative mindset

Required

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

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

Preferred

Exposure to CSV concepts preferred

Company

Alphanumeric Systems

Glassdoor2.9

At Alphanumeric, we are committed to bridging the gap between pharmaceutical companies, healthcare professionals (HCPs), patients, and caregivers through innovative and tailored communication solutions.

Founded in 1979

Raleigh, North Carolina, USA

201-500 employees

https://www.alphanumeric.com/

H1B Sponsorship

Alphanumeric Systems has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2022 (1)

2020 (1)