POSITION SUMMARY

The Quality Assurance (QA) Manager will be responsible for managing the Quality Unit and the quality operations within the 503A compounding pharmacy. This role ensures compliance with USP <795>, <797>, <800>, FDA 503A guidance, DEA regulations, and State Board of Pharmacy requirements. The QA Manager will be expected to provide leadership and oversight for all aspects of the quality management system (QMS), including documentation, batch review, product release, investigations, CAPA, environmental monitoring, audits, and regulatory inspections.
The QA Manager will be responsible for ensuring the integrity of all pharmacy operations in collaboration with the Pharmacist in Charge (PIC). This QA Manager will serve as the primary point of contact for quality matters between pharmacy operations and senior leadership, ensuring that patient safety, compliance, and continuous improvement are prioritized.

QUALIFICATIONS AND REQUIREMENTS

• Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, Microbiology, or related discipline (PharmD or Master’s degree preferred).
• Minimum 5 years of quality assurance experience in sterile compounding, sterile pharmaceuticals, or regulated healthcare manufacturing.
• At least 2 years in a supervisory or management role, overseeing QA personnel or compliance staff.
• Deep understanding of USP <795>, <797>, <800>, FDA 503A guidance, DEA regulations, and state Board of Pharmacy compounding regulations.
• Strong knowledge of aseptic technique, cleanroom operations, contamination control practices and sterile product testing protocols.
• Proven success in regulatory inspection preparation and response.
• Proficiency with electronic pharmacy platforms, document management systems, and investigation tracking tools.
• Ability to work collaboratively with pharmacists, technicians, and executive leadership.
• Exceptional written and verbal communication skills, with the ability to communicate effectively at all organizational levels.
  Job Type: Full-time
  Pay: $80,000.00 - $125,000.00 per year

Benefits:

• Dental insurance
• Employee discount
• Health insurance
• Paid time off
• Vision insurance

Application Question(s):

• Why are you applying for this role?

Experience:

• Quality assurance: 5 years (Required)
• supervisory or managerial: 2 years (Required)

Ability to Commute:

• Boca Raton, FL 33431 (Required)

Work Location: In perso

Training and Personnel Qualification

• Develop and implement QA and compliance training programs for pharmacists, technicians, and support staff.
• Ensure annual competency assessments for sterile compounding staff (aseptic technique, media fills, glove fingertip testing, hazardous drug handling).
• Maintain a training matrix to track staff completion of required programs.
• Serve as a mentor and resource for QA staff, providing coaching, feedback, and performance evaluations

Quality Oversight and Documentation Control

• Lead and manage the daily quality operations at the 503A site.
• Review and approve Master Formulation Records (MFRs) and Compounding Records (Batch Records) for completeness, accuracy, and compliance with SOPs and USP requirements.
• Ensure real-time line clearance and in-process quality checks are documented and reviewed.
• Manage document control system (policies, SOPs, forms, logs); ensure timely revision, approval, and archival of controlled documents.
• Establish and maintain a controlled document library with access permissions and version control.
• Oversee training assignments related to updated SOPs and new regulations.

Deviation, Complaints and CAPA Management

• Lead investigations for deviations, incidents, and non-conformances, ensuring root cause analysis and proper documentation.
• Manage the Corrective and Preventive Action (CAPA) system, ensuring actions are implemented, tracked, and verified for effectiveness.
• Review and close-out customer complaints; ensure complaints are investigated, documented, and resolved in compliance with regulatory standards.
• Track and trend deviations, complaints, and CAPA for recurring issues; escalate significant events to the Director of Quality, and Executive Management.

Environmental and Facility Oversight

• Oversee cleanroom environmental monitoring (viable/non-viable particles, surface testing, personnel monitoring) and ensure results are reviewed, trended, and compliant with USP <797>/<800>.
• Approve and monitor equipment qualification (IQ/OQ/PQ), calibration, and preventive maintenance schedules.
• Review and approve cleanroom certification reports, HVAC monitoring records, and ensure corrective actions for out-of-specification results.
• Ensure appropriate gowning qualification, aseptic technique competency, and media-fill validations are performed and documented for all sterile compounding personnel.
• Oversee cleaning validation, equipment qualification, and calibration programs.

Training and Personnel Qualification

• Develop and implement QA and compliance training programs for pharmacists, technicians, and support staff.
• Ensure annual competency assessments for sterile compounding staff (aseptic technique, media fills, glove fingertip testing, hazardous drug handling).
• Maintain a training matrix to track staff completion of required programs.
• Serve as a mentor and resource for QA staff, providing coaching, feedback, and performance evaluations.

Audits, Inspections, and Regulatory Compliance

• Prepare the pharmacy for regulatory inspections (FDA, DEA, State Board of Pharmacy, accreditation bodies).
• Conduct internal audits of compounding, quality, and support operations; ensure timely follow-up and CAPA.
• Ensure compliance with all federal and state reporting requirements (e.g., adverse events, recalls, regulatory notifications).
• Draft responses to regulatory observations (483s, warning letters) in collaboration with senior management.
• Always maintain inspection readiness, ensuring documentation is accurate, complete, and current.

Product Release and Recalls

• Authorize or reject compounded preparations prior to release based on record review and quality checks.
• Ensure product labeling, packaging, and distribution records meet all regulatory requirements.
• Lead recall management process if required, including health hazard evaluation, FDA communication, and recall effectiveness checks.
• Maintain recall documentation in accordance with 21 CFR Part 7 and Board of Pharmacy rules.

Continuous Improvement and Metrics

• Develop and track Quality Key Performance Indicators (KPIs), including:
• Number and types of deviations/complaints.
• CAPA completion rates and timeliness.
• Training compliance rates.
• Environmental monitoring compliance.
• Chair the Quality Management Review (QMR) with executive leadership, presenting trends and continuous improvement initiatives.
• Implement lean quality practices to streamline operations while maintaining compliance.