QMS Specialist

The Quality Assurance Specialist is responsible for executing the logistical needs of the company's Quality Management System (QMS), ensuring compliance with relevant clinical, regulatory, and industry standards, and driving continuous quality improvement across processes and deliverables. Own, maintain, and execute the company's Quality Management System. Draft, revise, review, approve, and manage SOPs, forms, templates, and QA records. Manage document control, version control, approvals, effective dates, archival, and controlled distribution. Execute internal audits, supplier audits, audit reports, CAPA tracking, and audit closure. Manage supplier qualifications, vendor oversight, risk assessments, questionnaires, and periodic reviews. Prepare the organization for sponsor, client, vendor, and regulatory audits. Manage deviations, nonconformances, quality issues, CAPAs, root cause analysis, effectiveness checks, and closure. Maintain training compliance, training matrices, read‑and‑understand records, and competency documentation. Support clinical quality oversight, documentation review, study quality records, and issue escalation. Maintain inspection readiness and ensure records comply with ALCOA++ data integrity principles. Track and report quality metrics, trends, audit findings, CAPA status, and vendor performance. Prepare management review inputs, QA updates, trackers, dashboards, and quality reports. Conduct regulatory watch activities and assess impact to internal procedures and practices. Provide QA guidance to personnel on GCP, procedures, documentation, CAPA, audit readiness, and quality risk management. Qualifications Bachelor's degree in life sciences or related field (required) 2+ years of Quality Assurance experience, preferably in a Contract Research Organization, Pharmaceutical, or Medical Device environment Exposure to auditing and regulatory inspection experience Strong interpersonal skills for interactions with internal and external clients Able to work independently Ability and willingness to travel as needed Knowledge & Skills Working knowledge of FDA, ICH, ISO, GxP, pharmaceutical, and medical device regulations for clinical trials Excellent written/oral communication and analytical skills Working knowledge of ICH E6(R3) Consistently displays a positive, patient attitude and extends respect and courtesy toward supervisors and peers alike Proven organizational, prioritization, and teamwork abilities Adept at working independently and collaboratively in fast‑paced settings Enthusiasm, attention to detail, results‑driven, high integrity Exposure to or basic understanding of Computer System Validation within regulated environments, including developing and managing CSV programs compliant with FDA 21 CFR Part 11, GAMP 5, and EU Annex 11, and skill in validation lifecycle activities is a plus Understanding of data privacy regulations including GDPR and HIPAA, with ability to enforce compliant data protection policies, is a plus #J-18808-Ljbffr ClinLab Solutions Group