About the Company
Reports To Quality Director of Operations
About the Role
The Quality Engineer – Sterile Compounding is responsible for maintaining and improving the Quality Management System (QMS) within a 503A sterile compounding pharmacy in compliance with USP, FDA expectations, and applicable state regulations. This role expands beyond traditional QA Specialist responsibilities to include equipment qualification (IQ/OQ/PQ), process validation, environmental control strategy, and continuous process improvement. The Quality Engineer ensures that sterile compounding operations are scientifically controlled, validated, and inspection-ready at all times.
Responsibilities
- Support and maintain elements of the Quality Management System (QMS)
- Author, revise, and execute technical operations (IQ/OQ/PQ) protocols, and technical reports
- Ensure USP procedures are scientifically sound and effectively implemented
- Lead deviation, investigation, and CAPA processes with a risk-based approach
- Perform quality risk assessments (FMEA, risk ranking, etc.)
- Analyze and trend quality data (EM, deviations, complaints, audit findings)
- Support internal audits, gap assessments, and regulatory inspections (FDA, State Boards)
Lead and execute equipment qualification lifecycle:
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
Develop and approve qualification protocols and reports for:
- Cleanroom HVAC systems with HEPA filtration systems
- Laminar airflow workbenches (LAFW), BSCs (Biological Safety Cabinets)
- Temperature mappings
- Critical compounding equipment (autoclave and oven)
Ensure calibration and preventive maintenance programs are effective
Support cleanroom certification reviews and requalification activities
Design and execute process validation strategies for sterile compounding
Lead aseptic process simulations (media fills) and requalification programs
Develop validation protocols including:
- Worst-case conditions
- Process challenge studies
- Hold time studies
Evaluate process capability and variability
Ensure validated state is maintained through lifecycle monitoring
Oversee viable and non-viable environmental monitoring program
Perform trend analysis and statistical evaluation of EM data
Establish alert/action levels and contamination control strategies
Lead investigations into EM excursions and implement corrective actions
Support contamination control strategy (CCS) aligned with USP
Lead root cause investigations using structured methodologies (5 Whys, Fishbone, etc.)
Develop and implement effective CAPAs
Monitor CAPA effectiveness and closure timelines
Identify process improvement opportunities using data and trends
Drive continuous improvement initiatives across sterile operations
Ensure personnel qualification programs are compliant and effective:
- Aseptic technique qualification
- Media fill certification
- Gowning qualification
- Visual inspection and labeling qualification program
- Support development of training materials and technical instruction
- Evaluate operator performance and requalification needs
- Review and approve Certificates of Analysis (COAs)
- Support supplier qualification and risk assessment
- Ensure incoming materials meet sterile compounding requirements
- Participate in vendor audits and quality agreements
Qualifications - Required
- Bachelor’s degree in Engineering, Life Sciences, or related field
- 5+ years experience in sterile compounding, pharmaceutical quality, or regulated environment
- Strong knowledge of USP and aseptic processing principles
- Experience with equipment qualification (IQ/OQ/PQ) and/or process validation
- Knowledge of quality systems, investigations, and CAPA
Qualifications – Preferred
- Experience in GMP regulated industry and/or aseptic sterile operations
- Familiarity with USP
- Experience with cleanroom design and contamination control strategy
- Exposure to FDA inspections or regulatory audits
- Lean/Six Sigma or quality certification (ASQ CQE, CQA, etc.)
Skills & Competencies
- Strong technical writing (protocols, reports, investigations)
- Analytical thinking and problem-solving capability
- Ability to interpret data and apply statistical tools
- Attention to detail with strong compliance mindset
- Cross-functional collaboration and communication
- Proficiency in Excel and quality management systems
Working Conditions
- Work in ISO-classified cleanroom environments
- Required gowning and aseptic practices
- Combination of desk-based analysis and floor support
- Occasional lifting and standing in controlled environments
Key Performance Indicators (KPIs)
- Equipment qualification on-time completion (IQ/OQ/PQ)
- Process validation success and state of control
- Environmental monitoring trend performance
- Deviation and CAPA closure effectiveness
- Inspection readiness and audit outcomes
- Training and qualification compliance rates
