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Quality Systems Specialist

Empower Pharmacy

Houston (TX)

On-site

USD 80,000 - 105,000

Full time

6 days ago
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Job summary

An innovative healthcare company is seeking a Quality Systems Specialist to enhance their Quality Management System. This role is pivotal in ensuring compliance and driving continuous improvement in quality processes. You will collaborate with cross-functional teams to maintain regulatory readiness and support strategic decision-making. Join a mission-driven organization that values people, quality, and innovation, and be part of a team that is making a real difference in healthcare accessibility and affordability. If you thrive in a fast-paced environment and are passionate about quality, this is the opportunity for you!

Benefits

Medical coverage
Dental coverage
Vision coverage
401(k) matching
Paid time off
Wellness perks
IV therapy
Compounded medications

Qualifications

  • 2+ years of experience in quality assurance or quality systems.
  • Strong knowledge of regulatory compliance and quality standards.

Responsibilities

  • Maintain and improve the Quality Management System (QMS).
  • Support supplier management and ensure product integrity.
  • Collaborate cross-functionally to enhance quality processes.

Skills

Problem-solving
Collaboration
Communication
Good Manufacturing Practices
Regulatory compliance
Continuous improvement

Education

Bachelor's degree in Pharmaceutical Sciences
Bachelor's degree in Engineering
Bachelor's degree in Chemistry
Bachelor's degree in Biology

Tools

Quality Management System (QMS)
Document control systems

Job description

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Location: Houston, Texas 77064, United States

Posted: April 30, 2025

Job Type: Full Time

Req# 4144

Quality

Company Overview

Empower is a visionary healthcare company committed to providing quality, affordable medication to millions of patients across the nation. We hold the distinguished position of being the largest 503A compounding pharmacy and FDA-registered 503B outsourcing facility in the country serving the functional medicine markets.

What sets us apart is our relentless focus on four core values: People, Quality, Service and Innovation. Our dedicated team of professionals collaboratively works to break new ground in the fields of manufacturing, distribution and quality control, providing a uniquely integrated approach to healthcare. Leveraging our vertical integration of the pharmaceutical supply chain, state-of-the-art technology, and a commitment to excellence, we are constantly pushing the boundaries of what is possible in medication accessibility and affordability.

You're not just starting a job; you're joining a mission. We believe in empowering our team to innovate, grow, and drive real change in the healthcare industry. If you're a forward-thinker who thrives in a fast-paced, transformative environment, Empower is the place for you. Here, you’ll be encouraged to share your ideas, expand your skill set, and contribute to projects that genuinely make a difference. We prioritize the well-being of our team members, and we offer a supportive and engaging workplace where your contributions are not just recognized but celebrated.

Let’s revolutionize healthcare, together. Join us and be a part of something extraordinary.

Position Summary

Quality is the backbone of Empower Pharmacy’s commitment to delivering safe, effective, and affordable medications. As a quality systems specialist, you will play a key role in maintaining and improving our Quality Management System (QMS), ensuring compliance, and driving continuous improvement across critical quality processes. This position offers the opportunity to collaborate cross-functionally, enhance supplier quality, and support strategic decision-making—directly contributing to expanding access to innovative healthcare solutions.

Duties And Responsibilities

  • Administers and maintains the QMS by reviewing and revising Standard Operating Procedures and Work Instructions, ensuring compliance with regulatory requirements and internal policies.
  • Supports key quality systems, including Annual Product Review, Corrective and Preventive Actions (CAPAs), non-conformance management, and change control, while collaborating cross-functionally to implement corrective actions, monitor effectiveness, enhance product and process quality, and support documentation, reporting, and audits for regulatory readiness and operational excellence.
  • Supports the supplier management program by assisting in supplier evaluations, tracking supplier quality issues, and coordinating failure investigations and corrective action requests to maintain product and process integrity.
  • Supports the routine review of metric data to ensure quality systems and processes are properly documented, compliant, and inspection-ready for regulatory bodies such as the Food and Drug Administration, Drug Enforcement Administration, and State Board of Pharmacy while facilitating quality management reviews to provide top management with insights into Quality Management System performance, identify improvement opportunities, and guide strategic resource allocation.
  • Provides guidance and support to cross-functional teams on Quality System procedures and best practices, promoting a culture of compliance, efficiency, and continuous improvement within the organization.

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. The employee is 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.

Knowledge And Skills

  • Strong problem-solving, collaboration, and communication skills, with the ability to convey complex quality concepts and drive continuous improvement.
  • Proficiency in Good Manufacturing Practices, quality system regulations, equipment qualification, process validation, deviation investigations, CAPA, document control, and regulatory audit support.

Key Competencies

  • Customer Focus: Ability to build strong customer relationships and deliver customer centric solutions.
  • Optimizes Work Processes: Know the most effective and efficient processes to get things done, with a focus on continuous improvement.
  • Collaborates: Builds partnerships and works collaboratively with others to meet shared objectives.
  • Resourcefulness: Secures and deploys resources effectively and efficiently.
  • Manages Complexity: Makes sense of complex, high quality, and sometimes contradictory information to effectively solve problems.
  • Ensures Accountability: Holds self and others accountable to meet commitments and objectives.
  • Situational Adaptability: Adapts approach and demeanor in real time to match shifting demands of different situations.
  • Communicates Effectively: Develops and delivers multi-mode communications that convey a clear understanding of the unique needs of different audiences.

Values

  • People: Our people define who we are as a company, and we believe that understanding and addressing the needs of our team, clients, and community is fundamental to fostering a culture of support and growth.
  • Quality: Quality stands at the core of our mission, reflecting our commitment to excellence in every medication we produce.
  • Service: We are here to serve others. Every interaction with our patients, providers, employees and other stakeholders comes from a place of service.
  • Innovation: By continuously exploring new methodologies and embracing technology, we ensure that every solution we offer is at the forefront of pharmaceutical care.

Experience and Qualifications

  • Minimum of 2 years of experience in quality assurance or quality systems within pharmaceutical or healthcare manufacturing, including equipment qualification, process validation, regulatory compliance, and support for regulatory audits.
  • Requires a bachelor’s degree in pharmaceutical sciences, engineering, chemistry, biology, or a related field, or equivalent experience.
  • Preferred certifications include Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), Good Manufacturing Practices Certification, Certified Pharmaceutical Good Manufacturing Practices Professional (CPGP), and Lean Six Sigma Green Belt or higher.

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/

Seniority level
  • Seniority level
    Entry level
Employment type
  • Employment type
    Full-time
Job function
  • Job function
    Quality Assurance
  • Industries
    Pharmaceutical Manufacturing

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