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Diagnostic Solutions Laboratory, LLC · 1 month ago

Quality Assurance/Quality Control Manager

Alpharetta, GA

Full-time

Onsite

Senior Level

5+ years exp

Diagnostic Solutions Laboratory is seeking a Quality Assurance/Quality Control Manager to oversee the laboratory's quality management system. The role involves coordinating regulatory activities, managing QA/QC staff, and ensuring compliance with standards set by CLIA and OSHA.

BiopharmaBiotechnologyClinical TrialsPharmaceuticalPrecision Medicine

Responsibilities

Oversee and manage QA/QC staff, ensuring responsibilities are performed accurately and efficiently

Collaborates with the Lab Manager and department supervisors to monitor and reinforce technician adherence to quality processes

Develop, implement, and monitor departmental goals, KPIs, and quality metrics aligned with organizational objectives

Lead proactive quality initiatives focused on continuous improvement, preventive action, and risk mitigation

Evaluate and approve SOPs, validation reports, and training documentation to ensure accuracy and compliance

Serve as the primary liaison with regulatory and accrediting bodies during audits, inspections, and certifications

Collaborate with leadership to establish training programs that ensure staff competency and regulatory compliance

Drive the implementation of new quality systems, policies, and electronic quality management systems (eQMS) to enhance data integrity and operational efficiency

Monitor department resource needs, staffing levels, and workload distribution to maintain optimal operational efficiency

Prepare and deliver reports on quality performance, audit findings, and compliance trends to senior leadership

Develops and defines material conformance specifications

Qualification

CLIA standardsQuality Management SystemLeadership skillsLIMS experienceEQMS experienceRisk managementRoot cause analysisStatistical process controlCommunication