Quality Control Analyst I - EM 503B

Empower Pharmacy•Houston, TX

2d•Onsite

About The Position

Empower Pharmacy is a visionary healthcare company dedicated to making quality, affordable medication accessible to millions of patients nationwide. As the nation’s most advanced 503A compounding pharmacy and FDA-registered 503B outsourcing facility, we’re redefining what’s possible in personalized medicine and pharmaceutical manufacturing. We’re 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 is built on four core values: People, Quality, Service, and Innovation. Guided by these principles, we’ve created a uniquely integrated healthcare platform powered by advanced technology, operational excellence, and a relentless commitment to patient care. From manufacturing and quality control to distribution and customer experience, our teams work together to raise industry standards, expand access to critical medications, and improve outcomes for patients and providers across the country. At Empower, joining our team means more than starting a new role. It means becoming part of a mission-driven organization that’s transforming healthcare at scale. We invest deeply in our people, encourage bold thinking, and create opportunities for growth, leadership, and innovation at every level. Your ideas matter here, your development is supported, and the work you do has a direct impact on the lives of millions. If you thrive in a fast-moving, purpose-driven environment where innovation, collaboration, and ambition come together, Empower Pharmacy is the place for you. Let’s transform healthcare together. POSITION SUMMARY The Product and Labeling Inspector ensures product integrity, labeling accuracy, and regulatory compliance across 503A and 503B operations. This role owns inspection execution, deviation identification, and release readiness within a high-throughput, quality-critical environment. The inspector leverages AI-enabled tools to detect anomalies, streamline documentation, and enhance inspection consistency. Operating at P80–P90 performance expectations, this individual delivers precision, speed, and accountability, directly impacting patient safety, audit readiness, and operational excellence across manufacturing, packaging, and distribution workflows.

Requirements

Strong understanding of GMP, 503A/503B regulations, and quality systems within pharmaceutical manufacturing environments.
Ability to leverage AI tools for inspection accuracy, data analysis, and continuous improvement initiatives effectively.
High attention to detail with strong analytical and systems-thinking capabilities in regulated production environments.
Effective communication and documentation skills ensuring clarity, compliance, and cross-functional alignment under pressure.
Minimum two years experience in pharmaceutical manufacturing, quality inspection, or regulated production environment with proven performance.
Demonstrated success identifying defects, ensuring compliance, and supporting audit readiness in high-throughput operations environments.
Experience working within 503A or 503B environments or similarly regulated pharmaceutical or healthcare manufacturing settings.
Proven ability to use digital or AI tools to enhance inspection accuracy, reporting efficiency, and quality outcomes.

Nice To Haves

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.

Responsibilities

Perform detailed inspections of products and labels ensuring accuracy, compliance, and defect-free release using AI-assisted detection tools.
Validate batch records, ensuring completeness, traceability, and alignment with GMP requirements using AI-supported document analysis tools.
Execute sampling procedures ensuring representative selection, integrity, and compliance with quality standards using digital tracking systems.
Ensure inspections meet 503A and 503B regulatory requirements using AI tools to monitor compliance deviations and trends.
Detect, document, and escalate discrepancies in products or labeling using AI-driven anomaly detection and reporting systems.
Prepare inspection data and documentation to support internal and external audits, ensuring readiness and accuracy at all times.
Identify inspection inefficiencies and recommend improvements using AI insights to enhance quality, speed, and consistency.
Analyze inspection data trends using AI tools to drive proactive quality improvements and reduce recurring issues.
Maintain strict adherence to SOPs while contributing to updates based on operational feedback and inspection outcomes.