Quality Control Analyst I - EM 503B (2nd shift)

Position Summary

Quality Control Analyst I – Environmental Monitoring (EM) drives microbiological assurance and cleanroom integrity, directly safeguarding product quality, regulatory compliance, and patient outcomes across Empower’s 503A/503B operations. This role owns environmental monitoring execution, data integrity, and quality documentation while enabling scalable, audit-ready manufacturing. Leveraging AI as a force multiplier, the analyst accelerates data review, anomaly detection, and decision-making to enhance speed, accuracy, and risk mitigation. Operating in a hyper-growth, highly regulated environment, the position demands disciplined execution, cross-functional collaboration, and continuous learning. Success requires talent capable of rigorous problem-solving, precise adherence to aseptic standards, and proactive identification of quality risks, ensuring consistent delivery of high-quality, compliant medications at scale while continuously improving processes through data-driven insights and supporting rapid commercialization of therapies without compromising compliance or operational excellence and enterprise-level quality governance alignment.

Duties and Responsibilities

Environmental Monitoring

• Sample Collection: Execute environmental monitoring across classified cleanrooms, collecting viable and non-viable samples while ensuring strict adherence to aseptic techniques and regulatory standards. Utilize AI-enabled tools to optimize sampling schedules, detect environmental trends, and enhance data accuracy, enabling proactive contamination control and supporting scalable manufacturing operations in a high-growth, highly regulated pharmaceutical environment.
• Trend Analysis: Analyze environmental monitoring data to identify patterns, deviations, and emerging risks using AI-driven analytics for faster and more precise interpretation. Translate findings into actionable insights that improve contamination control strategies, strengthen cleanroom performance, and ensure sustained compliance with regulatory expectations while supporting operational scalability and manufacturing excellence.
• Deviation Response: Investigate environmental excursions and anomalies, applying structured root cause analysis and AI-assisted diagnostics to accelerate resolution and prevent recurrence. Collaborate cross-functionally to implement corrective and preventive actions that enhance process reliability, maintain audit readiness, and reinforce quality systems in alignment with Empower’s regulatory and operational standards.
  
  

Quality Assurance Execution

• Data Review: Perform comprehensive review of microbiological and quality data, ensuring accuracy, completeness, and compliance with regulatory requirements. Leverage AI tools to streamline data verification, identify inconsistencies, and improve decision-making speed, enabling timely product release and strengthening overall quality assurance processes within a fast-paced, highly regulated environment.
• Documentation Control: Maintain precise and audit-ready quality documentation, including environmental records, calibration logs, and process data. Utilize digital and AI-supported systems to enhance data integrity, traceability, and accessibility, ensuring compliance while enabling efficient audits and inspections critical to sustaining Empower’s growth and regulatory standing.
• Sample Coordination: Coordinate submission and tracking of samples for laboratory analysis, ensuring timely processing and accurate reporting. Apply AI-enabled workflow optimization to improve turnaround times, reduce errors, and enhance coordination across teams, supporting efficient quality operations and consistent delivery of compliant pharmaceutical products.
  
  

Operational Support And Compliance

• Process Support: Support aseptic manufacturing operations by verifying equipment setup, monitoring process conditions, and ensuring adherence to established procedures. Integrate AI insights to enhance process consistency, detect potential risks early, and improve execution quality, contributing to reliable production outcomes and sustained compliance in a dynamic manufacturing environment.
• Audit Readiness: Prepare for and support internal and external audits by ensuring documentation accuracy, process transparency, and compliance with regulatory standards. Utilize AI tools to streamline audit preparation, identify gaps, and enhance readiness, reinforcing Empower’s commitment to quality and regulatory excellence in a rapidly scaling organization.
• Continuous Improvement: Drive continuous improvement initiatives by identifying inefficiencies, leveraging AI-driven insights, and implementing process enhancements that increase speed, quality, and compliance. Collaborate with cross-functional teams to embed best practices, strengthen quality systems, and support Empower’s mission of delivering high-quality, affordable medications at scale.
  
  

Knowledge and Skills

• Strong knowledge of aseptic processing, environmental monitoring, and microbiological testing, with ability to apply AI-driven tools for enhanced data analysis, contamination control, and quality decision-making.
• Proficiency in regulated documentation practices, data integrity principles, and digital quality systems, ensuring audit readiness and compliance within 503A/503B pharmaceutical environments.
• Analytical and problem-solving capabilities with experience leveraging technology to identify trends, investigate deviations, and implement effective Corrective and Preventive Actions (CAPA).
• Effective collaboration and communication skills, enabling cross-functional alignment, operational efficiency, and execution excellence in fast-paced, highly regulated manufacturing settings.
  
  

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

• Minimum of 1 year of experience in a quality or manufacturing role within pharmaceutical, medical device, or allied health sciences, with equivalent education considered in place of experience.
• Bachelor's degree in microbiology, earth science or other related field or equivalent experience.
• Demonstrates strong organizational skills, attention to detail, and teamwork, with the ability to follow established procedures and practices in a regulated environment.
• Possesses knowledge of aseptic operations, state and federal regulations, microbiological testing, and lab equipment, with the ability to perform calculations, aseptically gown, and work in cleanroom settings with cleaning agents and hazardous chemicals.
  
  

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.