Empower Pharmacy

Quality Operations Specialist 503B (1st shift)

Houston, TX

Sponsorship not specifiedDetected 7 days ago

Data AnalysisExcelHRISGMPFDA RegulatoryLeadershipCommunicationCollaborationAdaptabilityMicrosoft Office

About the role

The Quality Operations Specialist ensures consistent delivery of safe, sterile, and compliant pharmaceutical products, directly impacting patient outcomes and regulatory standing.
Leveraging AI as a force multiplier, the Specialist enhances review speed, improves deviation detection, strengthens root cause analysis, and enables data-driven decision-making at scale.
Operating with high autonomy, this role integrates quality into operational execution while continuously improving systems and processes.

Release Support: Support product release readiness by verifying data integrity and completeness while ensuring alignment with regulatory expectations and quality standards.
Deviation Handling: Identify, document, and support triage of deviations, ensuring timely escalation and compliance with internal procedures and regulatory requirements.
Root Cause Analysis: Perform structured root cause analysis using data-driven methodologies to uncover underlying issues and support effective corrective actions.
CAPA Support: Assist in the development and implementation of corrective and preventive actions, tracking effectiveness and closure.
Environmental Monitoring: Perform and support environmental monitoring activities to ensure compliance with sterility and contamination control standards.
Operational Support: Collaborate with cross-functional teams to resolve quality issues, improve workflows, and support high-quality execution.
Customer Focus: Builds trust through customer-centric solutions.
Optimizes Work Processes: Drives efficiency with continuous improvement.
Collaborates: Partners effectively to achieve shared goals.

While performing the responsibilities of the job, the employee is required to talk and hear.
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.
Minimum of 4 years of directly related experience.
Bachelor of Science in a science-related discipline required.
Proficiency in Microsoft Office, including Excel, Word, PowerPoint, and Outlook.
Experience in sterile and non-sterile manufacturing and knowledge of state and federal regulations required.
Strong attention to detail, organizational, and prioritization skills.

Strong knowledge of cGMP regulations, sterile and non-sterile manufacturing processes, and quality systems.
Proficiency in data analysis, root cause investigation methodologies, and CAPA processes.
Strong organizational, prioritization, and multitasking skills in fast-paced, regulated environments.
Effective communication and cross-functional collaboration skills.
Experience and

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.

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.
Empowering people defines who we are.

This listing is sourced directly from Empower Pharmacy's careers page and normalized into a canonical job model.