Quality Operations Technician
Core
Safeguards product quality, patient safety, and regulatory readiness by executing quality operations and oversight activities in a 503A/503B compounding environment.
Role type
Quality Operations Technician (Pharmaceutical Manufacturing)
Builds
Reliable medication production and uninterrupted business performance for patients nationwide
Domain
Healthcare / Pharmaceutical Manufacturing / Quality Control
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, batch record review, deviation identification, trend analysis, audit support, corrective action management, regulatory inspection readiness, data-driven quality analysis, AI-enabled tool usage, cross-functional collaboration
Preferred skills
Knowledge of 503A and 503B regulations, laboratory equipment familiarity, environmental monitoring, structured problem-solving methodologies
Technologies
AI-enabled monitoring tools, digital quality systems, data analytics platforms, quality management systems
Responsibilities
Maintain compliance with cGMP requirements and internal quality standards; Review batch records and quality documentation for accuracy and completeness; Support internal audits and regulatory inspections; Conduct routine inspections of equipment and controlled environments; Analyze quality data to identify recurring issues and improvement opportunities; Investigate quality events and assist with corrective and preventive actions
Seniority
Entry-level to Mid-level, hands-on IC
