Microbiologist II 503A

Empower Pharmacy•Houston, TX

21h

About The Position

The Microbiologist II 503A safeguards product quality, patient safety, and regulatory readiness by performing microbiological testing, environmental monitoring, investigations, and data analysis for Empower’s 503A and 503B compounding operations. The role is accountable for accurate, timely laboratory execution, identifying deviations, and contributing to improvements that support reliable product release, compliance, and operational growth. It uses AI-enabled analytics, digital workflows, and automation tools to support decision-making, testing precision, trend visibility, and quality outcomes in a fast-paced, highly regulated environment. The position maintains laboratory readiness, coordinates samples and testing priorities, investigates microbiological risks and out-of-trend results, and supports quality systems, audits, and regulatory inspections. It works with Quality, Production, Validation, Manufacturing, Engineering, and Quality Assurance teams to support investigations, process changes, equipment implementation, and laboratory improvements. The role also requires ongoing development of technical expertise in microbiology, aseptic processing, contamination control, and regulatory expectations.

Requirements

Bachelor’s degree in Microbiology, Biology, Chemistry, Biochemistry, or a related scientific discipline.
Strong understanding of microbiological testing methodologies, environmental monitoring, aseptic processing, contamination control, 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 skills, including the ability to investigate deviations, interpret microbiological trends, conduct root cause analysis, and implement corrective and preventive actions.
Excellent communication, collaboration, and organizational skills.
Ability to manage competing priorities and maintain documentation accuracy in a fast-paced, high-growth operational environment.
Ability to work independently, execute with precision, adapt quickly to change, and contribute to collaborative 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 for 503A compounding operations.
Use AI-enabled laboratory systems, automated trending tools, and digital workflows to support result interpretation, testing accuracy, documentation, and product disposition decisions.
Maintain laboratory readiness through equipment monitoring, media preparation, inventory management, calibration coordination, and documentation review.
Coordinate sample receipt, tracking, testing priorities, and workflows to support manufacturing schedules, stability programs, and release timelines.
Collaborate with Quality, Production, and Validation teams to support communication, issue resolution, and accurate microbiological records.
Investigate microbiological deviations, environmental excursions, out-of-trend results, and contamination risks using root cause methodologies and scientific analysis.
Execute microbiology activities in accordance with cGMP requirements, SOPs, aseptic processing standards, and regulatory expectations.
Maintain precise documentation and support compliance processes and inspection readiness using digital quality systems and automated workflows.
Support internal audits, regulatory inspections, and quality assessments with organized documentation, accurate records, and responsive issue resolution.
Identify compliance gaps, escalate operational risks, and support remediation activities.
Identify and implement opportunities to improve microbiological workflows, laboratory efficiency, environmental monitoring, testing reliability, and turnaround times.
Partner with Quality Assurance, Manufacturing, Engineering, and Validation teams on investigations, process changes, new equipment implementation, and operational improvements.
Continue developing technical expertise through training, research, and operational experience, and contribute ideas to improve quality, compliance, and laboratory performance.