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

Empower Pharmacy is a visionary healthcare company dedicated to making quality, affordable medication accessible to millions of patients nationwide. As the most advanced 503A compounding pharmacy and FDA-registered 503B outsourcing facility serving the functional medicine markets, we are proud to be recognized as one of Houston’s fastest-growing private companies and ranked #116 in Healthcare & Medical on the Inc. 5000 List for 2025.

Our strength lies in four core values—People, Quality, Service, and Innovation. Guided by these principles, we deliver a uniquely integrated approach to healthcare through vertical supply chain integration, advanced technology, and a relentless pursuit of excellence. From manufacturing to distribution to quality control, our teams work collaboratively to push boundaries, improve patient outcomes, and redefine medication accessibility.

At Empower, joining our team means more than starting a new job, it means becoming part of a mission to transform healthcare. We empower our employees to innovate, grow, and make a meaningful impact every day. Here, your ideas are valued, your growth is supported, and your contributions are celebrated.

If you thrive in a fast-paced, transformative environment where innovation meets purpose, Empower Pharmacy is the place for you. Let’s revolutionize healthcare together.

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 while improving accuracy and audit readiness. Operating within a high-growth, highly regulated 503A/503B environment, this position requires strong strategic thinking, disciplined execution, and rapid learning agility.

Responsibilities: 

Environmental Monitoring Execution

• Sampling Execution: Perform routine and advanced environmental monitoring across classified areas, ensuring precise sample collection, handling, and documentation aligned with cGMP standards.
• Data Integrity: Record, verify, and manage environmental monitoring data in compliance with Good Documentation Practices (GDP), ensuring accuracy, traceability, and visibility into environmental conditions.
• Trend Analysis: Analyze environmental monitoring trends to identify shifts, emerging risks, and contamination patterns, enabling proactive interventions and data-informed decisions.

Quality Investigation and Compliance

• Deviation Investigation: Lead investigations into out-of-specification and out-of-trend results using structured root cause methodologies and thorough documentation.
• CAPA Management: Support and execute corrective and preventive actions, ensuring timely resolution of quality issues and continuous improvement of environmental monitoring systems.
• Inspection Readiness: Prepare documentation, data packages, and responses for regulatory inspections in alignment with 503A/503B 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, processing, and data integrity.
• Program Support: Contribute to environmental monitoring program enhancements, including method improvements and technical troubleshooting.
• Documentation Management: Develop, revise, and maintain laboratory procedures, forms, and standard operating procedures (SOPs).

Knowledge and Skills:

• Strong knowledge of cGMP regulations, environmental monitoring principles, and contamination control strategies.
• Proficiency in laboratory systems, Microsoft Office applications, and digital quality systems.
• Strong problem-solving and analytical skills, with the ability to interpret complex datasets and identify risks.
• Effective communication and collaboration skills, including the ability to clearly explain technical findings to diverse stakeholders.

Experience and Qualifications: 

• Bachelor’s degree in Microbiology, Earth Science, or related field, or equivalent experience, with 1 year of experience in a Quality Control laboratory; or
• Associate’s degree in Microbiology, Earth Science, or related field, or equivalent experience, with 2 years of experience in a Quality Control laboratory.
• Strong time management skills with the ability to prioritize tasks while maintaining attention to detail in a fast-paced environment.
• Proficiency in Microsoft Office applications, including Excel, Word, PowerPoint, and Outlook.
• Experience in cGMP quality systems preferred.

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

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.