THIS ROLE IS FULLY ONSITE IN MIAMI GARDENS, FL, TO START.

ONCE OUR NEW FACILITY IN DAVIE, FL OPENS, YOU WOULD WORK FULLY ONSITE OUT OF THAT LOCATION.

KORE1, a nationwide provider of staffing and recruiting solutions, has an immediate opening for a Quality Control Specialist: CAPA + DEA Schedule III & IV compliance + retail OR 503A mail order OR 503B outsourcing facility

Position Overview:

We are looking for a detail-oriented Quality Control Specialist with strong experience in Corrective and Preventive Action (CAPA) processes and data analysis to identify, investigate, and resolve compliance and quality issues. This role supports the Compliance & Quality Control Officer and plays a critical part in ensuring the integrity, safety, and regulatory compliance of our pharmaceutical operations.

The Specialist will monitor quality systems for our 503a mail-order operations, receiving 503b outsourcing medications, retail pharmacy, controlled substances (Schedules III & IV), and warehouse operations. This individual will work cross-functionally with compliance, pharmacy, and warehouse teams to ensure all activities meet FDA, DEA, OSHA, and state regulatory standards.

Key Responsibilities

Quality Control & CAPA:

Implement and manage CAPA processes to identify root causes of compliance or quality issues.

Document, investigate, and resolve deviations, complaints, or incidents in a timely manner.

Recommend and implement corrective/preventive actions, tracking their effectiveness.

Data Analysis & Reporting

Collect and analyze data from pharmacy operations, controlled substance handling, warehouse activities, and outsourcing facilities.

Prepare regular reports and dashboards to highlight trends, risks, and areas needing improvement.

Provide data-driven recommendations to management for operational and compliance improvements.

Compliance Support

Assist with maintaining compliance with DEA regulations (Schedules III & IV), 50-state pharmacy licensure, and OSHA warehouse safety standards.

Support internal audits and external inspections by preparing records, reports, and documentation.

Ensure policies, SOPs, and training materials are followed consistently.

Collaboration & Training

Work closely with the Compliance & Quality Control Officer and team members to address quality challenges.

Provide training to staff on CAPA, quality assurance procedures, and documentation standards.

Promote a culture of continuous improvement and compliance awareness.

Qualifications:

Bilingual in English / Spanish (verbal / written) strongly preferred

Prior experience in 503A mail-order pharmacies, 503B outsourcing facilities, or retail pharmacies highly preferred.

Minimum 5 years of quality control, compliance, or regulatory experience in the pharmaceutical, biotech, or healthcare industry.

Strong knowledge and hands-on experience with CAPA systems and methodologies (corrective & preventative actions)

Experience supporting DEA Schedule III & IV compliance.

Background preparing for or supporting FDA, DEA, OSHA, or state board inspections.

Ability to analyze data, identify trends, and develop solutions to compliance/quality issues.

Proficiency with computer systems, reporting tools, and compliance tracking software.

Strong experience investigating and documenting deviations, complaints, or incidents in a regulated environment.

Familiarity with data analysis tools for identifying risks and compliance trends.

Knowledge of OSHA warehouse safety standards and 50-state pharmacy licensure compliance.

Proficiency with compliance tracking systems and reporting tools; ability to build dashboards, reports, and audit

Experience training staff on CAPA, QA, or compliance documentation standards.

Ability to work cross-functionally with compliance, pharmacy, and warehouse teams.

Ability to work under supervision but also independently when required.

Flexible schedule: able to adjust hours to support audits, inspections, or urgent compliance needs.

Work 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.

ABOUT KORE1 Specializing in professional and technical recruiting, KORE1 is committed to supporting top IT, Engineering, Creative, Scientific, Accounting and Finance professionals in their career paths. We build deep relationships with leading companies, connecting them to exceptional talent every day. With extensive industry expertise and unmatched opportunities, our goal is to provide a unique experience for our contractors and consultants as they prepare for their next role. We are passionate about matching the right people with the right companies.

Kore1 provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Kore1 complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. Kore1 expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. Improper interference with the ability of Kore1's employees to perform their job duties may result in discipline up to and including discharge.