What are the responsibilities and job description for the Quality Technician – 503A Sterile Compounding position at PACIFIC COMPOUNDING PHARMACY AND CONSULTATIONS, INC.?
Reports To
Quality Assurance (QA) Specialist or QA Manager
About the Role
The Quality Technician – Sterile Compounding supports daily quality and compliance activities for a 503A pharmacy limited to sterile operations under USP. This entry-level quality role focuses on documentation review, routine compliance checks, environmental monitoring support, and data tracking to ensure ongoing sterility assurance, regulatory compliance, and inspection readiness.
Responsibilities
- Maintain quality records, logs, and forms related to sterile compounding
- Perform routine reviews of compounding, cleaning, and monitoring logs
- Identify documentation errors and escalate discrepancies
- Support daily and scheduled cleanroom compliance walkthroughs
- Verify adherence to USP procedures and work instructions
- Escalate observed deviations or potential sterility risks
- Assist with documentation of deviations, incidents, and near-misses
- Collect and organize supporting records for investigations
- Track assigned corrective actions under QA supervision
Environmental Monitoring Support
- Assist with collection of viable and non-viable environmental monitoring samples
- Label, document, and track EM samples and results
- Notify QA leadership of out-of-specification or action-level results
- Maintain EM logs and assist with trending activities
Training & Qualification Support
- Track USP training and competency records
- Verify completion of gowning and aseptic technique qualifications
- Support onboarding documentation for sterile compounding personnel
- Assist with media fill and personnel qualification documentation
Materials & Sterile Supply Quality
- Assist with receipt and documentation of sterile supplies and components
- Verify lot numbers, expiration dates, and supporting documentation
- Support quarantine and release processes under QA direction
Audit & Inspection Readiness
- Support internal audits and mock inspections
- Organize quality records for FDA and state board inspections
- Provide documentation support during inspections
Qualifications – Required
- High school diploma or equivalent (Associate’s degree preferred)
- 2 years experience in sterile compounding, healthcare, or regulated environment
- Ability to follow written procedures and maintain accurate documentation
- Computer and data entry skills
Qualifications – Preferred
- Experience in a 503A sterile compounding pharmacy
- Cleanroom or ISO-classified environment experience
- Exposure to USP
- Pharmacy Technician Certification (CPhT)
Skills & Competencies
- High attention to detail and sterility awareness
- Strong documentation and organizational skills
- Ability to recognize and escalate sterility risks
- Clear written and verbal communication
- Ability to work in controlled environments
Working Conditions
- Sterile compounding and cleanroom environments
- Required gowning and controlled area access
- Standing, walking, and light lifting in controlled areas
Key Performance Indicators (KPIs)
- Accuracy of documentation reviews
- Environmental monitoring support compliance
- Training and qualification tracking accuracy
- Inspection readiness support effectiveness