Quality Control Analyst I - 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 I, Environmental Monitoring (EM), supports microbiological assurance and cleanroom integrity, directly safeguarding product quality, regulatory compliance, and patient outcomes across Empower’s 503B operations. This role supports 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 high-growth, regulated environment, this position requires disciplined execution, cross-functional collaboration, and continuous learning.

Responsibilities:

Environmental Monitoring

• Sample Collection: Execute environmental monitoring across classified cleanrooms, collecting viable and non-viable samples while ensuring adherence to aseptic techniques and regulatory standards.
• Trend Analysis: Analyze environmental monitoring data to identify patterns, deviations, and emerging risks, translating findings into actionable insights that improve contamination control strategies.
• Deviation Response: Investigate environmental excursions and anomalies using structured root cause analysis and collaborate cross-functionally to support corrective and preventive actions.

Quality Assurance Execution

• Data Review: Review microbiological and quality data for accuracy, completeness, and compliance with regulatory requirements.
• Documentation Control: Maintain audit-ready quality documentation, including environmental records, calibration logs, and process data.
• Sample Coordination: Coordinate submission and tracking of samples for laboratory analysis, ensuring timely processing and accurate reporting.

Operational Support and Compliance

• Process Support: Support aseptic manufacturing operations by verifying equipment setup, monitoring process conditions, and ensuring adherence to established procedures.
• Audit Readiness: Support internal and external audits by ensuring documentation accuracy, process transparency, and compliance with regulatory standards.
• Continuous Improvement: Identify inefficiencies and support process improvements that increase speed, quality, and compliance.

Knowledge and Skills: 

• Strong knowledge of aseptic processing, environmental monitoring, and microbiological testing.
• Understanding of regulated documentation practices, data integrity principles, and digital quality systems.
• Analytical and problem-solving skills with the ability to identify trends, investigate deviations, and support CAPA activities.
• Effective collaboration and communication skills in fast-paced, regulated manufacturing settings.

Experience and Qualifications: 

• Minimum of 1 year of experience in a quality or manufacturing role within pharmaceutical, medical device, or allied health sciences; equivalent education may be considered in place of experience.
• Bachelor’s degree in Microbiology, Earth Science, or related field, or equivalent experience.
• Strong organizational skills, attention to detail, and teamwork.
• Ability to follow established procedures and practices in a regulated environment.
• Knowledge of aseptic operations, state and federal regulations, microbiological testing, and laboratory equipment.
• Ability to perform calculations, aseptically gown, and work in cleanroom settings with cleaning agents and hazardous chemicals.

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.