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Pharmaceutical - Quality Assurance Lead

Pharmaceutical - Quality Assurance Lead

PrideStaffMiami, FL, United States
3 days ago
Job type
  • Full-time
Job description

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 305a mail-order operations, receiving 305b 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

  • 3+ 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.
  • Ability to analyze data, identify trends, and develop solutions to compliance / quality issues.
  • Proficiency with computer systems, reporting tools, and compliance tracking software.
  • Familiarity with DEA, FDA, OSHA, and state pharmacy regulations.
  • Strong organizational skills with high attention to detail.
  • Excellent written and verbal communication skills; bilingual (Spanish & English)preferred.
  • Ability to work under supervision but also independently when required.

    • Work Schedule

  • Standard : Monday to Friday, 8 : 00 a.m. - 4 : 30 p.m.
  • Must be flexible to adjust schedule to support audits, inspections, or urgent compliance needs.

    • Benefits :

  • 401(k) with up to 4% matching
  • Medical, dental, vision and life insurance
  • Paid time off
  • Paid public holidays

    • Compensation / Pay Rate (Up to) : $25.00 - $35.00 Per Hour

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    Quality Assurance Lead • Miami, FL, United States

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