Microbiologist II 503A

Empower Pharmacy; Houston (TX); Sur place; USD 75 000 - 110 000; Plein temps

Résumé du poste

Empower Pharmacy seeks a Microbiologist II to safeguard product quality and regulatory readiness by conducting microbiological testing, environmental monitoring, investigations, and data analysis. This role leverages AI-driven analytics, digital workflows, and automation to drive faster, more reliable decisions in a high-growth environment.

Responsibilities include testing execution, laboratory ownership, and cross-functional sample coordination to support manufacturing schedules, stability

Qualifications

• Bachelor’s degree in Microbiology, Biology, Chemistry, Biochemistry, or related scientific discipline.
• Minimum 2 years of microbiology laboratory experience in regulated environments preferred.
• Experience with environmental monitoring programs, investigations, and quality documentation preferred.

Responsabilités

• Testing Execution: Performs microbiological testing, environmental monitoring, growth promotion, and sample analysis supporting 503A operations with data integrity and compliance.
• Laboratory Ownership: Maintains readiness through equipment monitoring, media prep, inventory, calibration coordination, and documentation review.
• Sample Coordination: Coordinates sample receipt, testing prioritization, and workflow to support schedules and release timelines.

Connaissances

Microbiology testing

Environmental monitoring

Aseptic processing

cGMP compliance

Data integrity

Analytical problem solving

Communication

Collaboration

Organization

Formation

Bachelor’s degree in Microbiology, Biology, Chemistry, Biochemistry, or related scientific discipline

Outils

Laboratory Information Systems

Digital quality platforms

AI-enabled analytics tools

Automated workflows

Description du poste

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.

POSTITION SUMMARY:

Microbiologist II 503A safeguards product quality, patient safety, and regulatory readiness by executing microbiological testing, environmental monitoring, investigations, and data analysis supporting Empower’s high-growth 503A and 503B compounding operations. This role owns accurate, timely laboratory execution, deviation identification, and continuous improvement initiatives that strengthen release reliability, compliance performance, and operational scalability. Leveraging AI-enabled analytics, digital workflows, and automation tools as force multipliers, the Microbiologist II accelerates decision-making, improves testing precision, enhances trend visibility, and elevates quality outcomes across the microbiology program. Success requires disciplined execution, learning agility, strategic problem solving, and consistent performance within a fast-paced, highly regulated environment where P80–P90 talent combines technical depth, accountability, collaboration, and proactive risk management to support enterprise growth. The position influences audit readiness, manufacturing continuity, and customer trust through rigorous scientific standards daily.

Responsibilities:

Microbiology Operations

• Testing Execution: Performs microbiological testing, environmental monitoring, growth promotion, and sample analysis supporting 503A compounding operations while maintaining data integrity, procedural compliance, and operational efficiency. Utilizes AI-enabled laboratory systems, automated trending tools, and digital workflows to accelerate result interpretation, strengthen testing accuracy, improve documentation quality, and support timely product disposition decisions within a highly regulated manufacturing environment.
• Laboratory Ownership: Maintains laboratory readiness through disciplined execution of equipment monitoring, media preparation, inventory management, calibration coordination, and documentation review activities. Applies analytical thinking and AI-supported data insights to identify process variation, reduce operational risk, improve testing throughput, and strengthen compliance performance while consistently meeting quality standards, production timelines, and departmental objectives in a fast-paced growth environment.
• Sample Coordination: Coordinates sample receipt, tracking, testing prioritization, and workflow execution to support manufacturing schedules, stability programs, and release timelines. Partners cross-functionally with Quality, Production, and Validation teams while leveraging digital systems and AI-assisted analytics to improve visibility, enhance communication, accelerate issue resolution, and maintain accurate microbiological records supporting operational continuity and regulatory compliance expectations.

Quality and Compliance

• Deviation Management: Investigates microbiological deviations, environmental excursions, out-of-trend results, and contamination risks using structured root cause methodologies and scientific analysis. Integrates AI-enabled trend monitoring, historical data evaluation, and risk assessment tools to improve decision-making quality, strengthen corrective actions, reduce recurrence potential, and support audit-ready documentation aligned with FDA, USP, and internal quality requirements.
• Compliance Assurance: Executes microbiology activities in accordance with cGMP requirements, standard operating procedures, aseptic processing standards, and regulatory expectations supporting Empower’s 503A and 503B operations. Maintains precise documentation practices while using digital quality systems, automated workflows, and AI-supported review capabilities to improve accuracy, streamline compliance processes, and strengthen inspection readiness across laboratory operations.
• Audit Readiness: Supports internal audits, regulatory inspections, and quality assessments through organized documentation, accurate record management, and responsive issue resolution. Demonstrates execution rigor and learning agility by identifying compliance gaps, escalating operational risks appropriately, and applying AI-assisted reporting and data analysis tools to strengthen transparency, accelerate remediation activities, and sustain operational excellence within a hyper-growth environment.
• Process Enhancement: Identifies opportunities to improve microbiological workflows, laboratory efficiency, environmental monitoring effectiveness, and testing reliability through data-driven analysis and operational collaboration. Utilizes AI-powered analytics, automation technologies, and performance metrics to increase scalability, reduce manual inefficiencies, improve turnaround times, and support continuous improvement initiatives aligned with enterprise growth and evolving regulatory expectations.
• Technical Collaboration: Partners with Quality Assurance, Manufacturing, Engineering, and Validation teams to support investigations, process changes, new equipment implementation, and operational improvements. Applies scientific expertise, strategic thinking, and AI-enabled insights to evaluate microbiological risks, optimize laboratory processes, and improve cross-functional decision-making supporting product quality, patient safety, and sustainable operational performance.
• Knowledge Development: Continuously expands technical expertise in microbiology, aseptic processing, contamination control, and regulatory expectations through training, research, and operational experience. Demonstrates P80–P90 talent expectations by rapidly adapting to evolving technologies, leveraging AI as a force multiplier for learning and execution, and contributing innovative ideas that improve quality, compliance, and laboratory performance outcomes.

Knowledge and Skills:

• Strong understanding of microbiological testing methodologies, environmental monitoring practices, aseptic processing principles, contamination control strategies, and cGMP requirements supporting regulated pharmaceutical or healthcare manufacturing environments.
• Proficiency using laboratory information systems, digital quality platforms, AI-enabled analytics tools, and automated workflows to improve testing accuracy, data visibility, operational efficiency, and compliance execution.
• Demonstrated analytical problem-solving capabilities with experience investigating deviations, interpreting microbiological trends, conducting root cause analysis, and implementing effective corrective and preventive actions within regulated environments.
• Excellent communication, collaboration, and organizational skills with the ability to manage competing priorities, maintain documentation accuracy, and operate effectively within fast-paced, high-growth operational environments.

Experience and Qualifications:

• Bachelor’s degree in Microbiology, Biology, Chemistry, Biochemistry, or related scientific discipline required.
• Minimum 2 years of microbiology laboratory experience within pharmaceutical, biotechnology, healthcare, food manufacturing, or other highly regulated operational environments preferred.
• Experience supporting environmental monitoring programs, microbiological testing, investigations, and quality documentation within cGMP or similarly regulated environments preferred.
• Familiarity with USP requirements, aseptic processing standards, laboratory investigations, data integrity practices, and digital laboratory systems strongly preferred.
• Demonstrated ability to operate independently, execute with precision, adapt quickly to change, and contribute effectively within collaborative, high-performance teams.
• 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:

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.