Quality Control Specialist 503B

Empower Pharmacy is a visionary healthcare company dedicated to making quality affordable medication accessible to millions of patients nationwide. As the nations most advanced 503A compounding pharmacy and FDA-registered 503B outsourcing facility were redefining whats possible in personalized medicine and pharmaceutical manufacturing. Were proud to be recognized as one of Houstons 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 weve 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 thats 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. Lets transform healthcare together.

POSITION SUMMARY

Quality Control Specialist 503B protects product quality compliance and manufacturing continuity acrossEmpowers503A and 503B operations through inspection sampling testing coordination and documentation. This role ensuresaccurateexecution deviation identification and data integrity supporting patient safety and operational reliability. Leveraging AI-enabled quality systems analytics and automation the position improves review speed inspection accuracy and decision-making. Successrequiresexecution rigor learning agility and disciplined problem solving within a highly regulated fast-paced environment. P80P90 talentdemonstratesaccountability collaboration adaptability and quality leadership supporting operational scalability and businessgrowth.

RESPONSIBILITIES

Quality Operations

• Inspection Execution:Performs materialinspections sampling and quality verification supporting compliant manufacturing and product release. Utilizes AI-enabled systems and workflows to improve inspection accuracy processing speed and documentation quality while supporting reliable decision-making.
• Testing Coordination: Coordinates sample management testing activities and laboratory communication supporting product quality and operational continuity. Leverages AI-assisted analytics and digital systems to improve visibility reduce delays and strengthen compliance execution.
• Deviation Support:Draft Nonconformance investigations andassistininvestigationsimpact assessments deviation tracking and CAPAand change controlactivities supporting compliance and audit -powered analytics toidentifytrends improve responsiveness and strengthen root cause visibility.

Compliance And Documentation

• Record Accuracy:Maintainsaccurate audit-ready records supporting cGMP compliance and manufacturing systems and AI-assisted tools to improve data integrity reduce errors and strengthen process consistency.
• Regulatory Alignment:Executes quality activities aligned with FDA USP and company procedures supporting safe manufacturing operations. Leverages AI-enabled compliance tools to improve visibility and decision-making.
• Audit Readiness:Supports audits and inspections through organized documentation and adherence to -powered reporting tools to improve preparedness and compliance responsiveness.

Continuous Improvement

• Process Enhancement:Identifiesopportunities to improve workflows documentation and inspection processes. Uses AI-driven analytics and automation to improve efficiency compliance and operational performance.
• Cross functional Partnership:Collaborates with Manufacturing QA Warehouse and Laboratory teams to resolve issues and support operations. Leverages digital tools to improve communication and execution.
• Knowledge Development:Expandsexpertisein quality systems and regulatory standards whileleveragingAI tools to improve performance and adaptability in a fast-paced environment.

KNOWLEDGE AND SKILLS

• Strong understanding of quality control processes cGMP documentation practices inspection procedures deviation management and compliance standards supporting regulated manufacturing or pharmaceutical operations.
• Proficiency using electronic quality management systems digital documentation platforms AI-enabled analytics tools and automated workflows supporting operational efficiency and scalable compliance execution.
• Demonstrated analytical problem-solving capabilities with experience identifying quality risks supporting investigations improving documentation accuracy and managing competing priorities within fast-paced operational environments.
• Excellent communication collaboration and organizational skills with the ability to maintain documentation precision support cross-functional operations and adapt quickly to changing business requirements.

EXPERIENCE AND QUALIFICATIONS

• Bachelors degree in Biology Chemistry Quality Pharmaceutical Sciences Operations or related discipline preferred.
• Minimum 2 years of quality control manufacturing laboratory or regulated operational experience supporting pharmaceutical healthcare biotechnology or similarly regulated industries preferred.
• Experience supporting inspections quality documentation deviation management audit readiness and electronic quality systems strongly preferred.
• Familiarity with FDA regulations cGMP standards USP requirements AI-enabled quality technologies and digital workflow platforms preferred.
• Demonstrated ability to execute with precision adapt rapidly to changing operational demands and contribute effectively within collaborative high-performance teams.

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: 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.