Quality Control Specialist 503B

Empower Pharmacy; Houston, Northern (TX, KY); Hybrid; USD 65,000 - 90,000; Full time

Job summary

Empower Pharmacy is seeking a Quality Control Specialist for its 503B operations in Houston. You will protect product quality, ensure compliance, and support manufacturing continuity across 503A/503B using AI-enabled quality systems and rigorous documentation.

The role emphasizes data integrity, deviation investigations, and cross-functional collaboration with Manufacturing, QA, and Laboratory teams in a fast-paced, regulated environment.

Qualifications

• Bachelor’s degree in Biology, Chemistry, Quality, Pharmaceutical Sciences, Operations, or related discipline preferred.
• Minimum 2 years of quality control, manufacturing, laboratory, or regulated operational experience preferred.
• Experience supporting inspections, quality documentation, deviation management, audit readiness, and electronic quality systems preferred.
• Familiarity with FDA regulations, cGMP standards, USP requirements, and AI-enabled quality technologies preferred.

Responsibilities

• Quality Operations: Inspect, sample, and verify products; support compliant manufacturing and release with AI-assisted systems.
• Testing Coordination: Manage sample handling, testing activities, and lab communications to improve visibility and compliance.
• Deviation Support: Draft investigations, assist investigations, track deviations, and support CAPA/change control activities.

Skills

Quality control

cGMP

FDA regulations

AI-enabled analytics

Documentation

Education

Bachelor’s degree in Biology, Chemistry, Quality, Pharmaceutical Sciences, Operations

Job description

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:

Quality Control Specialist 503B protects product quality, compliance, and manufacturing continuity across Empower’s 503A and 503B operations through inspection, sampling, testing coordination, and documentation. This role ensures accurate execution, 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. Success requires execution rigor, learning agility, and disciplined problem solving within a highly regulated, fast-paced environment. Talent demonstrates accountability, collaboration, adaptability, and quality leadership supporting operational scalability and business growth.

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 andassistininvestigations,impact assessments, deviation tracking, and CAPAand change controlactivities supporting compliance and audit readiness.AppliesAI-powered analytics toidentifytrends, improve responsiveness, and strengthen root cause visibility.

Compliance And Documentation

• Record Accuracy :Maintainsaccurate, audit-ready records supporting cGMP compliance and manufacturing continuity.Usesdigital 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 procedures.UsesAI-powered reporting tools to improve preparedness and compliance responsiveness.
• 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:

• Bachelor’s 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.
• 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:

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.

Empower uses AI‑assisted tools throughout the hiring process. This may include resume and application screening, interview transcription, AI‑generated summaries and candidate assessments, interview evaluation, and candidate communications. Our AI tools are designed to complement, not replace, human decision‑making. Empower hiring teams review all AI outputs.

Your decision does not affect your eligibility or selection for employment. If you do not provide consent, your application will be reviewed without the use of AI‑assisted tools and you will be evaluated on the same criteria as all other candidates.

Illinois applicants: In accordance with the Illinois Artificial Intelligence Video Interview Act, Empower discloses that AI may be used to analyze video interview recordings, including evaluation of speech patterns, word choice, and responses to interview questions.

California applicants may exercise additional rights under the CCPA/CPRA as described in the Applicant Privacy Policy.

Texas applicants may exercise rights under the Texas Responsible AI Governance Act (TRAIGA) and the Texas Data Privacy & Security Act (TDPSA) as described in the Applicant Privacy Policy.

If I am a current Empower employee, I understand I should apply through the internal careers portal.

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self‑identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in Empower Pharmacy’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans’ Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service‑connected disability.

A "recently separated veteran" means any veteran during the three‑year period beginning on the date of such veteran's discharge or release from active duty in U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.