Quality Assurance Technician

Position Summary

The Quality Assurance Technician supports the pharmacy’s Quality Management System (QMS) and compliance programs by assisting with quality assurance activities, documentation review, environmental monitoring coordination, investigations, and regulatory readiness initiatives. This role helps ensure sterile and non-sterile compounding operations are performed in accordance with internal policies and procedures, current USP standards, state and federal regulations, and applicable quality and patient safety requirements. The Quality Assurance Technician works collaboratively with pharmacists, pharmacy technicians, production personnel, and leadership to support continuous quality improvement and maintain a culture of compliance and patient safety.

Quality Assurance & Compliance Support

• Aid in the implementation, maintenance, and continuous improvement of the pharmacy Quality Management System (QMS)
• Review batch records, compounding documentation, cleaning logs, and related records for completeness, accuracy, and compliance
• Support deviation, nonconformance, corrective and preventive action (CAPA), and change control processes
• Maintain quality records, logs, and compliance documentation in accordance with document control procedures
• Escalate quality concerns, documentation discrepancies, and compliance issues appropriately

Environmental Monitoring & Facility Compliance

• Assist with viable air, non-viable particle, and surface sampling activities
• Maintain environmental monitoring records including temperature, humidity, and pressure differential documentation
• Schedule and track cleanroom certifications
• Afford assistance with monitoring maintenance and calibration requirements for equipment and controlled environments
• Afford assistance in ensuring compliance with USP , USP , and applicable regulatory standards

Product & Process Quality Monitoring

• Afford assistance with quarantine, identification, and segregation of nonconforming materials or compounded preparations
• Coordinate or support sterility, endotoxin, potency, and outsourced laboratory testing activities
• Maintain and monitor quality metrics and environmental monitoring results
• Afford assistance in investigating product complaints, deviations, out-of-specification results, or quality events
• Afford participation in root cause analysis and corrective action follow-up activities

Documentation & Training Support

• Maintain controlled documents including SOPs, forms, logs, and quality records
• Afford assistance with employee training documentation and competency tracking
• Afford support to staff education initiatives related to quality assurance, compliance, and aseptic practices
• Afford assurance that documentation is completed accurately, legibly, and in a timely manner

Audit & Inspection Readiness

• Afford assistance with preparation for regulatory inspections, accreditation surveys, and internal audits
• Gather records and supporting documentation during inspections and audit activities
• Afford participation in implementation and follow-up of corrective actions resulting from inspections or audits
• Afford ongoing inspection readiness efforts throughout the pharmacy

Qualifications

• High school diploma or equivalent required
• Active pharmacy technician registration/licensure preferred, where applicable
• National pharmacy technician certification preferred
• Preferred experience in sterile or non-sterile compounding pharmacy
• Quality assurance or quality control programs
• USP , USP , and/or USP environments
• Regulated healthcare, pharmaceutical, or laboratory settings

Knowledge, Skills, and Abilities

• Strong attention to detail and documentation accuracy
• Understanding of aseptic technique and cleanroom practices preferred
• Strong organizational and time management skills
• Ability to communicate effectively with cross-functional teams
• Ability to identify, document, and escalate quality concerns appropriately
• Proficiency with electronic documentation systems and Microsoft Office applications preferred
• Ability to maintain confidentiality and professionalism in a regulated healthcare environment

Physical Requirements

• Ability to stand and walk for extended periods
• Ability to lift and transport supplies and equipment as needed
• Ability to work in cleanroom environments while wearing required PPE
• Ability to perform duties requiring repetitive hand movements and visual inspection tasks

Performance Expectations

• Maintain accurate, timely, and compliant documentation
• Adhere to all pharmacy policies, procedures, and regulatory requirements
• Support continuous quality improvement initiatives
• Promote a culture of compliance, accountability, and patient safety
• Demonstrate professionalism, teamwork, and attention to detail in all responsibilities