Quality Assurance Specialist

Empower Pharmacy; Houston (TX); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401(k) matching

Paid time off

Job summary

Empower Pharmacy in Houston seeks a Quality Assurance Specialist to strengthen site quality oversight, product integrity, and regulatory readiness within a fast-growing, highly regulated 503A/503B environment.

You will lead routine walkthroughs, investigations, and documentation, collaborate with regulatory teams, and drive corrective actions while upholding cGMP and FDA standards to ensure safe, high-quality medications for patients.

Qualifications

• 3+ years of pharma quality experience.
• Bachelor’s degree in life sciences or related field.
• CQA or CQIA certification preferred.

Responsibilities

• Lead site quality walkthroughs and risk assessments.
• Support deviation investigations and corrective actions.
• Maintain quality records and ensure inspection readiness.

Skills

cGMP knowledge

Documentation review

Root cause analysis

Cross-functional collaboration

MS Office

Education

Bachelor’s degree in life sciences/pharmaceutical sciences

Tools

Microsoft Excel

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 OVERVIEW:

The Quality Assurance Specialist strengthens site quality oversight, product integrity, and operational readiness across Empower’s compounding and manufacturing operations. In a hyper-growth, highly regulated 503A/503B environment, this individual contributor leads routine walkthroughs, conducts internal audits, and maintains accurate quality records that support safe, consistent medications. The role partners with site business units and regulatory teams to investigate deviations, assess risks, and implement corrective and preventive actions. Ownership includes timely documentation closure and archiving, inspection readiness preparation, and support for employee quality training. Success requires disciplined execution, sound judgment, attention to detail, and the ability to learn evolving requirements quickly. By connecting daily quality activities to broader operational priorities, the specialist identifies practical improvements, communicates issues clearly, and reinforces current Good Manufacturing Practices (cGMP) compliance without compromising patient safety or quality.

RESPONSIBILITIES:

Site Quality Oversight

• Site Walkthroughs : Lead routine walkthroughs of compounding and manufacturing areas to assess adherence to regulatory requirements, internal standards, and approved procedures.
• Risk Assessment : Collaborate with site business units and regulatory teams to assess quality risks and recommend actions that protect product integrity.
• Quality Training : Support training on regulatory expectations, internal quality metrics, and procedures to strengthen employee understanding and consistent adherence to requirements.

Investigations and Quality Improvement

• Deviation Investigations : Support cross-functional deviation investigations by reviewing relevant documentation and applying root cause analysis tools to help identify underlying quality issues.
• Corrective Actions : Implement assigned corrective and preventive actions arising from internal or external audits, coordinating with stakeholders to address identified deficiencies.
• Process Improvement : Identify practical opportunities to improve quality oversight and documentation workflows, partnering with colleagues to strengthen accuracy, consistency, and efficiency.

Documentation and Inspection Readiness

• Quality Records : Maintain complete, accurate quality records under enterprise Quality Assurance oversight, meeting regulatory requirements and internal policies for timely closure and archiving.
• Internal Audits : Conduct internal audits of site operations and documentation, record findings clearly, and communicate compliance gaps to relevant stakeholders.
• Inspection Support : Prepare inspection readiness documentation and support regulatory inspections by organizing quality records and providing accurate information within assigned responsibilities.

KNOWLEDGE AND SKILLS:

• Knowledge of current Good Manufacturing Practices, Food and Drug Administration requirements, and United States Pharmacopeia standards applicable to compounding and manufacturing.
• Ability to review quality documentation for accuracy and completeness, understand batch record flow, and maintain organized records through closure and archiving.
• Skill in root cause analysis, quality risk assessment, and process improvement methods to support investigations and implement corrective and preventive actions.
• Clear communication and collaborative problem-solving skills, with working knowledge of Microsoft Office tools for organizing quality information and coordinating cross-functional activities.

EXPERIENCE AND QUALIFICATIONS:

• At least 3 years of quality experience within pharmaceutical manufacturing, including practical application of cGMP principles and regulatory compliance requirements required.
• Bachelor’s degree in life sciences, pharmaceutical sciences, or a related discipline, or equivalent practical work experience relevant to pharmaceutical quality assurance required.
• Demonstrated accuracy in documentation review, understanding of batch record flow, working knowledge of Microsoft Office, and effective cross-functional communication required.
• Certified Quality Auditor (CQA) or Certified Quality Improvement Associate (CQIA) certification supporting expertise in auditing or quality improvement strongly 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.