Microbiologist II ; 2nd shift

Position Summary

Microbiologist II 503A safeguards product quality, patient safety, and regulatory readiness by executing microbiological testing, environmental monitoring, investigations, and data analysis supporting Empower’s high‑growth 503A and 503B compounding operations. This role owns accurate, timely laboratory execution, deviation identification, and continuous improvement initiatives that strengthen release reliability, compliance performance, and operational scalability. Leveraging AI‑enabled analytics, digital workflows, and automation tools as force multipliers, the Microbiologist II accelerates decision‑making, improves testing precision, enhances trend visibility, and elevates quality outcomes across the microbiology program.

Success requires disciplined execution, learning agility, strategic problem solving, and consistent performance within a fast‑paced, highly regulated environment where P80–P90 talent combines technical depth, accountability, collaboration, and proactive risk management to support enterprise growth. The position influences audit readiness, manufacturing continuity, and customer trust through rigorous scientific standards daily.

• Testing Execution: Performs microbiological testing, environmental monitoring, growth promotion, and sample analysis supporting 503A compounding operations while maintaining data integrity, procedural compliance, and operational efficiency. Utilizes AI‑enabled laboratory systems, automated trending tools, and digital workflows to accelerate result interpretation, strengthen testing accuracy, improve documentation quality, and support timely product disposition decisions within a highly regulated manufacturing environment.
• Laboratory Ownership: Maintains laboratory readiness through disciplined execution of equipment monitoring, media preparation, inventory management, calibration coordination, and documentation review activities. Applies analytical thinking and AI‑supported data insights to identify process variation, reduce operational risk, improve testing throughput, and strengthen compliance performance while consistently meeting quality standards, production timelines, and departmental objectives in a fast‑paced growth environment.
• Sample Coordination: Coordinates sample receipt, tracking, testing prioritization, and workflow execution to support manufacturing schedules, stability programs, and release timelines. Partners cross‑functionally with Quality, Production, and Validation teams while leveraging digital systems and AI‑assisted analytics to improve visibility, enhance communication, accelerate issue resolution, and maintain accurate microbiological records supporting operational continuity and regulatory compliance expectations.

• Deviation Management: Investigates microbiological deviations, environmental excursions, out‑of‑trend results, and contamination risks using structured root cause methodologies and scientific analysis. Integrates AI‑enabled trend monitoring, historical data evaluation, and risk assessment tools to improve decision‑making quality, strengthen corrective actions, reduce recurrence potential, and support audit‑ready documentation aligned with FDA, USP, and internal quality requirements.
• Compliance Assurance: Executes microbiology activities in accordance with cGMP requirements, standard operating procedures, aseptic processing standards, and regulatory expectations supporting Empower’s 503A and 503B operations. Maintains precise documentation practices while using digital quality systems, automated workflows, and AI‑supported review capabilities to improve accuracy, streamline compliance processes, and strengthen inspection readiness across laboratory operations.
• Audit Readiness: Supports internal audits, regulatory inspections, and quality assessments through organized documentation, accurate record management, and responsive issue resolution. Demonstrates execution rigor and learning agility by identifying compliance gaps, escalating operational risks appropriately, and applying AI‑assisted reporting and data analysis tools to strengthen…