Quality Control Specialist 503B

Empower Pharmacy Quality Control Specialist 503B Houston, TX May 5, 2026 Pay information not provided 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 Specialist safeguards product integrity and regulatory compliance, directly impacting patient safety, operational reliability, and Empower’s reputation in a highly regulated 503A/503B environment. This role owns end-to-end quality control activities including testing, data analysis, deviation investigation, and documentation, ensuring timely release of materials and products. Leveraging AI as a force multiplier, the specialist enhances testing precision, accelerates root cause analysis, and improves decision-making through predictive insights and trend identification. Operating within a hyper-growth context, this role demands P80–P90 talent capable of balancing strategic thinking with rigorous execution and continuous learning agility. The position partners cross-functionally to drive proactive quality improvements, strengthen compliance posture, and scale quality systems to meet increasing production demands while maintaining uncompromising standards. Responsibilities: Quality Execution Analytical Testing : Executes advanced analytical testing of raw materials, in-process samples, and finished products using technologies such as HPLC, FTIR, and endotoxin systems, integrating AI-assisted analytics to enhance accuracy, reduce variability, and accelerate release timelines while ensuring strict adherence to regulatory and internal quality standards. Data Integrity : Maintains rigorous data integrity through precise documentation, review, and verification of laboratory results, leveraging AI-enabled validation tools to detect anomalies, ensure audit readiness, and uphold compliance with FDA regulations and USP standards in a high-throughput environment. Release Decisions : Supports batch and material release decisions by synthesizing analytical data, deviation findings, and compliance requirements, utilizing AI-driven insights to improve decision quality, reduce cycle time, and ensure only compliant, high-quality products reach patients. Quality Systems and Compliance Deviation Management : Investigates deviations, out-of-specification results, and non-conformances using structured root cause methodologies enhanced by AI pattern recognition, delivering thorough documentation and corrective actions that prevent recurrence and strengthen overall quality system resilience. Regulatory Alignment : Ensures continuous alignment with 21 CFR Part 211, USP , , and standards by applying deep regulatory knowledge and AI-supported compliance monitoring tools to proactively identify gaps and sustain inspection readiness. Audit Support : Contributes to internal audits, inspections, and Material Review Board activities by preparing data, summarizing findings, and using AI tools to streamline audit preparation, improve transparency, and reinforce a culture of accountability and compliance excellence. Continuous Improvement and Collaboration Trend Analysis : Performs ongoing data trending and statistical analysis using AI-enabled platforms to identify emerging risks, optimize processes, and proactively mitigate quality issues before they impact production or compliance outcomes. Cross Collaboration : Partners with manufacturing, R&D, and external laboratories to coordinate testing, stability studies, and investigations, using AI-driven collaboration tools to enhance communication, reduce delays, and ensure alignment across functions. Process Enhancement : Drives continuous improvement initiatives by identifying inefficiencies in testing and quality workflows, applying AI-based optimization techniques to increase throughput, reduce errors, and scale quality operations in a rapidly growing organization. Knowledge and Skills: Strong expertise in analytical instrumentation, including HPLC, FTIR, TOC, and endotoxin testing, combined with the ability to leverage AI tools for data analysis, anomaly detection, and process optimization. Deep understanding of FDA regulations, USP standards, and 503A/503B compounding requirements, with demonstrated capability to apply compliance knowledge in complex, high-growth pharmaceutical environments. Advanced problem-solving and root cause analysis skills, integrating structured methodologies with AI-driven insights to improve accuracy, speed, and effectiveness of quality investigations. Effective collaboration and communication skills, with the ability to translate complex technical data into actionable insights and leveraged digital and AI tools to enhance cross-functional alignment. Experience and Qualifications: Minimum of 3 years' experience in pharmaceutical Quality Assurance, QC or Regulatory (or Compliance) experience required. Bachelor’s degree in chemistry, biology, or related field preferred. Demonstrates strong organizational and time management skills, proactive problem-solving, attention to detail, and the ability to work independently while analyzing details and making structured decisions. Possesses expertise in compound pharmacy practices, including United States Pharmacopeia , , and , Food and Drug Administration guidance, and 21 Code of Federal Regulations Part 211, with proficiency in writing reports, reviewing technical documents, handling hazardous chemicals, and working in cleanroom environments. 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: 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. #J-18808-Ljbffr Dormont Manufacturing Co