Quality Operations Technician

POSITION SUMMARY 

The Quality Operations Technician safeguards product quality, patient safety, and regulatory readiness by executing quality operations that directly enable reliable medication production and uninterrupted business performance. This role owns day-to-day quality oversight activities, including documentation review, inspections, monitoring, compliance support, deviation identification, and continuous improvement execution across Empower's 503A and 503B compounding environment. Leveraging AI as a force multiplier, the position uses data-driven insights to accelerate reviews, improve accuracy, strengthen decision-making, and scale quality outcomes without compromising compliance. Success requires disciplined execution, proactive problem solving, and cross-functional collaboration in a hyper-growth, highly regulated organization. High-performing talent demonstrates learning agility, strategic thinking, operational rigor, accountability, and a relentless commitment to quality excellence and continuous advancement while supporting scalable growth, inspection preparedness, operational resilience, and trust across all functions. 

RESPONSIBILITIES 

Quality Compliance 

• GMP Oversight: Maintain compliance with cGMP requirements, internal quality standards, and regulatory expectations across compounding operations. Use AI-enabled monitoring and review tools to identify risks, improve documentation accuracy, accelerate issue detection, and support consistent execution within Empower's highly regulated 503A and 503B environment.
• Record Integrity: Review batch records, logs, and quality documentation for completeness, accuracy, and compliance. Apply data-driven analysis and AI-assisted validation techniques to detect discrepancies, resolve exceptions efficiently, strengthen traceability, and prevent production delays while maintaining inspection readiness.
• Audit Readiness: Support internal audits, regulatory inspections, and quality assessments by maintaining organized records and ensuring procedural adherence. Leverage AI-supported reporting and trend analysis to improve visibility, enhance preparedness, and strengthen quality system performance across operational activities. 

Operational Excellence 

• Process Monitoring: Conduct routine inspections of equipment, controlled environments, and operational systems to verify performance against established standards. Utilize digital tools and AI-enhanced insights to identify deviations, prioritize corrective actions, and improve quality outcomes through proactive operational oversight.
• Trend Analysis: Analyze quality data, inspection findings, and operational metrics to identify recurring issues and improvement opportunities. Apply AI-driven analytics to accelerate root-cause identification, support informed decisions, and contribute to sustainable enhancements in efficiency, compliance, and product quality.
• Continuous Improvement: Participate in cross-functional initiatives focused on reducing risk, eliminating inefficiencies, and strengthening quality processes. Use structured problem-solving methodologies and emerging technologies to improve execution speed, scalability, consistency, and overall operational effectiveness. 

Collaboration And Capability 

• Team Support: Partner with manufacturing, quality, engineering, and compliance teams to address quality concerns and maintain alignment with organizational objectives. Foster accountability, communicate effectively, and contribute to timely resolution of issues impacting quality, safety, or productivity.
• Knowledge Development: Support training activities by reinforcing quality procedures, best practices, and regulatory expectations. Utilize AI-enabled learning resources and performance insights to accelerate capability development, improve knowledge retention, and strengthen workforce readiness in a dynamic growth environment.
• Issue Resolution: Investigate quality events, document findings, and assist with corrective and preventive actions. Apply critical thinking, learning agility, and technology-enabled workflows to resolve problems efficiently, reduce recurrence, and strengthen long-term quality system performance. 

KNOWLEDGE AND SKILLS 

• Knowledge of cGMP regulations, quality management systems, documentation controls, batch record review processes, and compliance requirements within highly regulated manufacturing or compounding environments.
• Ability to leverage AI-enabled tools, digital quality systems, and data analytics to improve review efficiency, decision quality, issue detection, and operational scalability.
• Strong analytical, organizational, and problem-solving capabilities with demonstrated attention to detail, risk awareness, and the ability to manage multiple priorities effectively.
• Excellent communication and collaboration skills with the ability to work cross-functionally, support training initiatives, and contribute to continuous improvement objectives. 

EXPERIENCE AND QUALIFICATIONS 

• Minimum of 1 year of experience in quality operations, quality control, or regulatory compliance within a pharmaceutical or healthcare environment, with a focus on cGMP and compounding operations preferred.
• Requires a Bachelor's degree in life sciences, chemistry, or a related field.
• Good attention to detail, problem-solving, and organizational skills, with the ability to collaborate across departments and ensure adherence to quality and regulatory standards while fostering a culture of continuous improvement.
• Proficiency in quality management systems, documentation practices, and regulatory compliance standards, with basic knowledge of laboratory equipment, environmental monitoring, and 503A and 503B regulations.