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 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 supports quality control activities including testing, data analysis, deviation investigation, and documentation to ensure 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.
Resposibilities:
Quality Execution
- Analytical Testing: Execute analytical testing of raw materials, in-process samples, and finished products using technologies such as HPLC, FTIR, TOC, and endotoxin systems.
- Data Integrity: Maintain data integrity through accurate documentation, review, and verification of laboratory results in alignment with FDA regulations and USP standards.
- Release Support: Support batch and material release decisions by synthesizing analytical data, deviation findings, and compliance requirements.
Quality Systems and Compliance
- Deviation Management: Investigate deviations, out-of-specification results, and non-conformances using structured root cause methodologies.
- Regulatory Alignment: Support compliance with 21 CFR Part 211, USP 795, USP 797, and USP 800 standards.
- Audit Support: Contribute to internal audits, inspections, and Material Review Board activities by preparing data and summarizing findings.
Continuous Improvement and Collaboration
- Trend Analysis: Perform ongoing data trending and analysis to identify emerging risks, optimize processes, and proactively mitigate quality issues.
- Cross-Functional Collaboration: Partner with manufacturing, R&D, and external laboratories to coordinate testing, stability studies, and investigations.
- Process Enhancement: Support continuous improvement initiatives that increase throughput, reduce errors, and scale quality operations.
Knowledge and Skills:
- Strong knowledge of analytical instrumentation, including HPLC, FTIR, TOC, and endotoxin testing.
- Understanding of FDA regulations, USP standards, and 503A/503B compounding requirements.
- Strong problem-solving and root cause analysis skills.
- Effective communication skills with the ability to translate technical data into actionable insights.
- Ability to leverage AI and digital tools to support data analysis, anomaly detection, documentation, and process optimization.
Experience and Qualifications:
- Minimum of 3 years of experience in pharmaceutical Quality Assurance, Quality Control, Regulatory, or Compliance required.
- Bachelor’s degree in Chemistry, Biology, or a related field preferred.
- Strong organizational and time-management skills, with attention to detail and the ability to work independently.
- Experience with compound pharmacy practices, including USP 795, USP 797, USP 800, FDA guidance, and 21 CFR Part 211.
- Experience writing reports, reviewing technical documents, handling hazardous chemicals, and working in cleanroom environments.
- Certified Pharmacy Technician preferred.
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.