THIS ROLE IS FULLY ONSITE IN MIAMI GARDENS, FL
KORE1, a nationwide provider of staffing and recruiting solutions, has an immediate opening for a Quality Control Lead - Florida RPT, Non-Sterile Compounding Pharmacy, Lab Oversight, Bilingual in Spanish
The Quality Control Lead is responsible for ensuring the quality and compliance of all materials used in compounding operations. Quality Control Lead to oversee the quality and compliance of all materials used in compounding operations. This role ensures safe and efficient 503A non-sterile and hazardous compounding practices while maintaining continuous compliance with USP 795, USP 800, FDA, DEA, OSHA, HIPAA, and state board regulations across all compounding facilities.
Key Responsibilities
Compounding / Quality & Compliance
- Own and maintain all compounding documentation including equipment logs, cleaning records, destruction records, and other compliance-related documentation.
- Design, deliver, and document initial and ongoing training for compounding staff; assess and verify staff competency.
- Supervise laboratory QC activities, review analytical data, and identify trends.
- Investigate and document deviations, including temperature excursions and out-of-spec results, and implement CAPA.
- Ensure compliance with USP
and
, FDA, DEA, OSHA, HIPAA, and state regulations.
General Administrative Duties
Direct the Pharmacy Technician Program from onboarding through completion, ensuring alignment with Florida state requirements.Coordinate locker / asset assignments for new hires in partnership with HR.Conduct cross-departmental USP / job-role assessments and provide corrective coaching as needed.Monitor regulatory updates (OSHA, USP, FDA, DEA) and integrate changes into practice.Track facility maintenance schedules, ensure preventive maintenance is completed, and issue monthly compliance reports.Compliance & Licensing
Write, revise, and manage SOPs, policies, and procedures (P&P), maintaining version control and staff acknowledgement.Lead inspection-readiness activities, including mock audits, document room preparation, and coordination with FDA, DEA, OSHA, and state board inspectors.Serve as HIPAA Privacy & Security Officer for the compounding division; manage daily compliance, breach investigations, and staff HIPAA training.Supervise or coordinate QC laboratory activities and ensure documentation integrity.Qualifications :
Fluent in English / Spanish (written / verbal) requiredActive Florida Registered Pharmacy Technician LicenseMinimum 2-3 years of experience in non-sterile or sterile compounding QA / QC or complianceHands-on experience with USPand USP
compliance requirements
Experience investigating deviations, such as temperature excursions or out-of-spec results, and implementing CAPAPrior involvement in inspection readiness, including mock audits, document preparation, and regulatory inspections (FDA, DEA, OSHA, state boards)Experience writing, revising, and managing SOPs, policies, and procedures, including version controlExperience training and assessing compounding or pharmacy staff for competencyFamiliarity with documentation systems such as cleaning logs, equipment logs, destruction records, or other compliance tracking toolsExperience supervising or coordinating QC laboratory activitiesAbility to track maintenance schedules and issue compliance reportsKnowledge of HIPAA compliance, including breach investigations and staff trainingProficiency with Microsoft Office (Word, Excel, Outlook, PowerPoint)Experience with pharmacy software systems; familiarity with compliance tracking tools a plusAbility to work 100% onsite at Miami Gardens, FL compounding facilitiesFlexible schedule, including potential weekends or urgent compliance supportWork Schedule :
Standard : Monday to Friday.Evenings or weekends may be required to support audits, inspections, or urgent compliance issues.Compensation depends on experience but is typically $55-75K based on a 44-hour workweek. However, we are willing to send qualified candidates over budget.
