Sterile Manufacturing Operator Lead 503B (1st shift)

Empower Pharmacy is a visionary healthcare company dedicated to making quality affordable medication accessible to millions of patients nationwide. As the nations most advanced 503A compounding pharmacy and FDA-registered 503B outsourcing facility were redefining whats possible in personalized medicine and pharmaceutical manufacturing. Were proud to be recognized as one of Houstons 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 weve 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 thats 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. Lets transform healthcare together.

POSITION SUMMARY

The Sterile Manufacturing Operator Lead drives execution across aseptic preparation mixing vial filling documentation and ISO-classified cGMP operations protecting product quality patient access and production schedules. Owning workflow coordination workforce deployment training escalation and continuous improvement this role converts standards into disciplined floor performance. AI serves as a force multiplier by accelerating production analysis expanding visibility improving decision quality strengthening documentation review and scaling learning without compromising Empowers hyper-growth highly regulated 503A/503B environment the Lead partners across Manufacturing Quality and Technical Operations to sustain readiness resolve constraints and raise operating maturity. Success requires strategic thinking execution rigor learning agility sound judgment and resilience to deliver precise outcomes in a fast-moving sterile manufacturing setting while modeling Empowers values of people quality service and innovation.

RESPONSIBILITIES

Sterile Operations Leadership

• Shift Leadership: Lead daily sterile manufacturing activities across preparation mixing aseptic vial filling cleaning and disinfection translating production schedules into clear priorities and coordinated execution. Monitor staffing material readiness equipment status and workflow constraints throughout the shift. Use AI-enabled dashboards and exception alerts to improve visibility accelerate decisions and maintain safe compliant output within Empowers fast-paced 503A/503B manufacturing environment while reinforcing ownership accountability performance and consistent communication across assigned production activities.
• Workforce Coordination: Allocate operators across critical work centers based on qualification workload production risk and schedule demand while supporting breaks coverage and rapid response to changing priorities. Coach team members in real time and escalate staffing gaps early. Apply AI-assisted capacity insights to anticipate bottlenecks balance labor efficiently and improve throughput without weakening aseptic controls documentation quality or employee safety. Support effective handoffs across shifts and departments.
• Floor Ownership: Maintain visible ownership of sterile manufacturing performance by confirming room readiness line clearance gowning discipline material flow and adherence to standard operating procedures. Identify deviations from expected conditions and initiate timely containment or escalation. Use digital and AI-supported checklists to strengthen consistency accelerate verification and identify recurring risk patterns while ensuring production commitments are met with uncompromising attention to quality service and patient impact.

Quality and Compliance Execution

• Aseptic Compliance: Execute and reinforce cGMP ISO-classified and aseptic processing requirements during compounding and filling activities including environmental controls cleaning disinfection and contamination prevention practices. Observe behaviors correct unsafe or noncompliant actions and involve Quality when required. Leverage AI-guided knowledge tools to retrieve approved procedures efficiently reinforce training and improve decision consistency while ensuring human judgment and controlled documentation remain central to each decision and escalation pathway.
• Record Review: Review batch records logbooks and manufacturing documentation for completeness accuracy traceability and alignment with approved procedures before routing for formal Quality review. Resolve clear documentation issues promptly and escalate potential non-conformances. Use AI-assisted review capabilities to identify missing fields inconsistent entries and recurring error trends increasing speed and quality while preserving data integrity operator accountability and compliance with Empowers regulated 503A/503B requirements.
• Issue Response: Respond to equipment alarms process interruptions documentation discrepancies and potential non-conformances by stabilizing operations gathering facts and escalating through established pathways. Support root-cause analysis and implementation of corrective actions within role authority. Apply AI-enabled trend analysis to connect recurring events prioritize investigation signals and improve response speed while partnering with Quality Engineering and leadership to protect product people and production continuity through timely fact-based actions and documented follow-through.

Performance and Capability Improvement

• Data Improvement: Analyze production quality downtime and labor data to identify trends recurring losses and practical opportunities for continuous improvement. Translate findings into actions that strengthen cycle time schedule adherence right-first-time performance and operational reliability. Use AI to accelerate pattern recognition scenario evaluation and visual reporting then validate insights through floor observation and cross-functional review before implementing changes within Empowers high-growth highly regulated manufacturing environment. Communicate recommendations with supporting evidence and measurable impact.
• Team Development: Train and mentor new hires and developing operators on sterile processes approved procedures equipment use documentation expectations and disciplined problem-solving. Confirm understanding through observation feedback and qualification support. Use AI-enabled learning tools to personalize reinforcement generate practice scenarios and identify knowledge gaps at scale while maintaining approved content controls and building a culture of learning agility collaboration accountability safe behaviors and sustained technical excellence.
• Cross-Functional Partnership: Collaborate with Manufacturing Quality Engineering Warehouse and Technical Operations to coordinate priorities resolve constraints and improve sterile manufacturing readiness. Communicate status risks and support needs clearly across shifts and functions. Use AI-supported summaries and action tracking to accelerate alignment improve follow-through and strengthen decision quality while contributing floor expertise that enables scalable processes successful launches and consistent service to patients and providers.

KNOWLEDGE AND SKILLS

• Working knowledge of sterile compounding aseptic vial filling ISO-classified environments cGMP practices contamination control cleaning disinfection and controlled manufacturing documentation.
• Ability to lead daily execution allocate labor coach peers manage changing priorities and communicate risks clearly across Manufacturing Quality Engineering and support teams.
• Proficiency with Microsoft Excel or comparable spreadsheet tools production metrics basic math digital work instructions and responsible use of AI-enabled analysis and knowledge tools.
• Strong attention to detail resourcefulness situational adaptability accountability and learning agility with disciplined judgment in fast-paced highly regulated manufacturing operations.

EXPERIENCE AND QUALIFICATIONS

• Minimum of one (1) year of compounding experience required.
• High school diploma or equivalent required.
• Demonstrated strong attention to detail self-motivation and teamwork skills with the ability to work effectively in a controlled environment and follow detailed instructions.
• Proficiency in Microsoft Excel or other spreadsheet software and basic math skills required; experience in a lead or mentoring role 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: 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.