What are the responsibilities and job description for the Quality Assurance Consultant position at Alphanumeric Systems Inc and Careers?
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:
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
About Alphanumeric Systems Inc.:
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!
Salary : $70 - $175