Microbiologist II 503A

Empower Pharmacy•Houston, TX

About The Position

The Microbiologist II 503A safeguards product quality, patient safety, and regulatory readiness by carrying out microbiological testing, environmental monitoring, investigations, and data analysis for Empower’s 503A and 503B compounding operations. The role is responsible for accurate and timely laboratory execution, identifying deviations, and contributing to improvements that strengthen product release reliability, compliance, and operational scalability. It uses AI-enabled analytics, digital workflows, and automation tools to support decision-making, testing precision, trend visibility, and microbiology program outcomes. The position works in a fast-paced, highly regulated environment and contributes to audit readiness, manufacturing continuity, and customer trust through rigorous scientific practices. It collaborates with Quality, Production, Validation, Manufacturing, Engineering, and Quality Assurance teams, and supports laboratory readiness, investigations, process changes, and continuous improvement.

Requirements

Bachelor’s degree in Microbiology, Biology, Chemistry, Biochemistry, or a related scientific discipline.
Strong understanding of microbiological testing methodologies, environmental monitoring practices, aseptic processing principles, contamination control strategies, and cGMP requirements in regulated pharmaceutical or healthcare manufacturing environments.
Proficiency with laboratory information systems, digital quality platforms, AI-enabled analytics tools, and automated workflows.
Analytical problem-solving ability, including interpreting microbiological trends, investigating deviations, conducting root-cause analysis, and implementing corrective and preventive actions.
Strong communication, collaboration, and organizational skills; ability to manage competing priorities and maintain accurate documentation.
Ability to operate independently, execute with precision, adapt to change, and contribute effectively in collaborative, high-performance teams.

Nice To Haves

At least 2 years of microbiology laboratory experience in pharmaceutical, biotechnology, healthcare, food manufacturing, or another highly regulated operational environment.
Experience supporting environmental monitoring programs, microbiological testing, investigations, and quality documentation in cGMP or similarly regulated environments.
Familiarity with USP requirements, aseptic processing standards, laboratory investigations, data integrity practices, and digital laboratory systems.

Responsibilities

Perform microbiological testing, environmental monitoring, growth promotion, and sample analysis supporting 503A compounding operations.
Maintain data integrity, procedural compliance, testing accuracy, documentation quality, and timely result interpretation.
Maintain laboratory readiness through equipment monitoring, media preparation, inventory management, calibration coordination, and documentation review.
Coordinate sample receipt, tracking, testing prioritization, and workflow execution for manufacturing schedules, stability programs, and release timelines.
Partner with Quality, Production, and Validation teams to improve visibility, communication, issue resolution, and microbiological recordkeeping.
Investigate microbiological deviations, environmental excursions, out-of-trend results, and contamination risks using structured root-cause methods and scientific analysis.
Execute microbiology activities in accordance with cGMP requirements, standard operating procedures, aseptic processing standards, and regulatory expectations.
Support internal audits, regulatory inspections, and quality assessments through organized documentation, accurate record management, and responsive issue resolution.
Identify and implement opportunities to improve microbiological workflows, laboratory efficiency, environmental monitoring effectiveness, and testing reliability.
Collaborate with Quality Assurance, Manufacturing, Engineering, and Validation on investigations, process changes, new equipment implementation, and operational improvements.
Continue developing technical expertise in microbiology, aseptic processing, contamination control, and regulatory expectations.
Use AI-enabled analytics, automated trending tools, digital workflows, and automation technologies to improve testing, data analysis, compliance, and laboratory performance.