Quality Control Analyst II - EM 503B (1st shift)

Position Summary

The Quality Control Analyst II – Environmental Monitoring (EM) drives contamination control and product quality by executing and enhancing environmental monitoring programs critical to Empower’s manufacturing reliability and regulatory compliance. This role owns routine and complex monitoring, investigations, and data integrity, ensuring actionable insights that protect product sterility and patient safety. Leveraging AI as a force multiplier, the analyst accelerates trend analysis, deviation detection, and decision-making at scale while improving accuracy and audit readiness. Operating within a hyper-growth, highly regulated 503A/503B environment, this position demands strong strategic thinking, disciplined execution, and rapid learning agility to continuously elevate quality systems, support inspections, and enable efficient, compliant production outcomes.

Duties and Responsibilities

Environmental Monitoring Execution

• Sampling Execution: Perform routine and advanced environmental monitoring across classified areas, ensuring precise sample collection, handling, and documentation aligned with current Good Manufacturing Practices (cGMP) standards while leveraging AI-enabled scheduling and tracking tools to optimize coverage, reduce human error, and maintain continuous state of control in dynamic manufacturing environments.
• Data Integrity: Record, verify, and manage environmental monitoring data in compliance with Good Documentation Practices (GDP), utilizing AI-assisted validation and anomaly detection to ensure accuracy, traceability, and real-time visibility into environmental conditions impacting product quality and regulatory adherence.
• Trend Analysis: Analyze environmental monitoring trends using AI-driven analytics to identify shifts, emerging risks, and contamination patterns, enabling proactive interventions, improved process understanding, and faster, data-informed decisions that strengthen contamination control strategies and operational resilience.
  
  

Quality Investigation And Compliance

• Deviation Investigation: Lead investigations into out-of-specification and out-of-trend results, applying structured root cause methodologies augmented by AI insights to accelerate identification of failure modes, ensure thorough documentation, and implement effective, sustainable corrective actions.
• CAPA Management: Support and execute Corrective and Preventive Actions (CAPA) by integrating AI-powered risk prioritization and effectiveness tracking, ensuring timely resolution of quality issues and continuous improvement of environmental monitoring systems within regulatory expectations.
• Inspection Readiness: Prepare documentation, data packages, and responses for regulatory inspections, using AI tools to streamline audit readiness, enhance document accuracy, and ensure consistent alignment with evolving 503A/503B regulatory requirements and internal quality standards.
  
  

Laboratory Operations And Support

• Sample Handling: Manage environmental monitoring samples and materials within the laboratory, ensuring proper chain of custody, storage, and processing while leveraging digital tools and AI workflows to enhance efficiency, reduce turnaround times, and maintain data integrity.
• Program Support: Contribute to environmental monitoring program enhancements, including method improvements and technical troubleshooting, using AI-enabled simulations and insights to optimize processes, resolve issues efficiently, and support scalable, high-quality manufacturing operations.
• Documentation Management: Develop, revise, and maintain laboratory procedures, forms, and Standard Operating Procedures (SOPs), utilizing AI-assisted document generation and review to ensure clarity, compliance, and continuous alignment with best practices and regulatory expectations.
  
  

Knowledge and Skills

• Strong knowledge of cGMP regulations, environmental monitoring principles, and contamination control strategies, with the ability to apply AI tools for enhanced data analysis, compliance monitoring, and process optimization.
• Proficiency in laboratory systems, Microsoft Office applications, and digital quality systems, with experience leveraging AI-driven platforms for trend analysis, reporting automation, and decision support.
• Advanced problem-solving and analytical skills, with the ability to interpret complex datasets, identify risks, and implement data-driven solutions in fast-paced, regulated environments.
• Effective communication and collaboration skills, enabling cross-functional alignment, training delivery, and clear articulation of technical findings to diverse stakeholders.
  
  

Key Competencies

• Customer Focus: Builds trust through customer-centric solutions
• Strategic AI: Guides responsible AI adoption and adaptation
• Optimizes Work Processes: Drives efficiency with continuous improvement
• Collaborates: Partners effectively to achieve shared goals
• Resourcefulness: Secures and deploys resources efficiently
• Manages Complexity: Simplifies and solves complex challenges
• Ensures Accountability: Delivers on commitments with integrity
• Situational Adaptability: Adjusts approach to shifting conditions
• Communicates Effectively: Tailors messages to diverse audiences
  
  

Values

• People: Empowering people defines who we are
• Quality: Excellence in every product, every time
• Service: Serving others is our highest purpose
• Innovation: Advancing care through technology and discovery
  
  

Experience And Qualifications

• Bachelor’s degree in microbiology, earth science, or other related field or equivalent experience with 1 year of experience in a Quality Control (QC) laboratory, or
• Associate’s degree in microbiology, earth science, or other related field or experience with 2 years of experience in a QC laboratory required.
• Demonstrates strong time management skills and the ability to prioritize tasks effectively while maintaining attention to detail in a fast-paced environment.
• Possesses proficiency in Microsoft Office applications, including Excel, Word, PowerPoint, and Outlook, with experience in cGMP quality systems preferred.
  
  

Benefits

Employee Benefits, Health and Wellness:

We offer comprehensive benefits to support your health, well-being, and future, including medical, dental, and vision coverage, paid time off, 401(k) matching, wellness perks, IV therapy, and compounded medications.

Learn more: https://careers.empowerpharmacy.com/benefits/

Physical Requirements

While performing the responsibilities of the job, the employee is required to talk and hear. The employee is often required to remain in a stationary position for a significant amount of the workday and frequently use their hands and fingers to handle or feel in order to access, input, and retrieve information from the computer and other office productivity devices. Employees are regularly required to move about the office and around the corporate campus. The employee is regularly required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl.