Quality Control Specialist
About The Position
We are seeking a detail-oriented Quality Control Technician to support quality assurance and compliance activities within a pharmaceutical and compounding environment. This role supports the Compliance & Quality Control team by assisting with quality monitoring, documentation, and regulatory compliance to ensure the safety, integrity, and accuracy of pharmacy operations. The Quality Control Technician will help monitor quality systems across 503A pharmacy operations, receipt of 503B outsourced medications, non-sterile compounding, controlled substances (Schedules III & IV), retail pharmacy activities, and related warehouse operations. This position works closely with pharmacy, compliance, and warehouse teams to ensure adherence to FDA, DEA, OSHA, and state pharmacy regulations.
Requirements
- 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.
- Pharmacy Technician License or willingness to obtain one
- 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 close attention to detail.
- Excellent written and verbal communication skills
- Ability to work under supervision but also independently when required.
Nice To Haves
- bilingual (Spanish & English) preferred.
Responsibilities
- Implement and manage CAPA processes to identify root causes of compliance or quality issues.
- Document, investigate, and resolve deviations, complaints, or incidents promptly.
- Recommend and implement corrective/preventive actions, tracking their effectiveness.
- 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.
- 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.
- 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
Benefits
- Competitive salary.
- Bonus program based on productivity and efficiency.
- Flexible scheduling options.
- Opportunities for growth in a rapidly expanding telepharmacy practice.
- Collaborative and innovative work environment focused on patient safety and compliance.
- 401(k) with up to 4% matching
- Medical, dental, vision and life insurance
- Paid time off
- Paid public holidays
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
Number of Employees
11-50 employees
