Quality Control Microbiologist Supervisor

Ascend Advanced Therapies is seeking a Quality Control Microbiologist Supervisor to perform testing in compliance with QMS policies and procedures, company standards, and applicable regulatory requirements, including GMP, safety, and environmental requirements.

• Perform testing in compliance with QMS policies and procedures, company standards, and applicable regulatory requirements, including GMP, safety, and environmental requirements.
• Support laboratory startup, qualification activities, and Environmental Monitoring Performance Qualification (EMPQ) studies for manufacturing and support areas.
• Perform routine environmental and utility monitoring activities, including sampling, testing, troubleshooting, and investigation of atypical results.
• Conduct microbiological testing of drug substance, drug product, environmental monitoring, and utility samples in accordance with approved procedures and regulatory requirements.
• Perform routine monitoring, sampling, and testing of Water for Injection (WFI) systems to ensure compliance with established specifications and site monitoring programs.
• Perform work while fully gowned within the clean room environment of the gene therapy production facility, including environmental and utility monitoring during aseptic processing and filling.
• Perform microbiological assays, including bioburden, endotoxin, mycoplasma, sterility, pharmaceutical water testing, and gas testing.
• Support onboarding, qualification, and lifecycle management of laboratory equipment and GMP software systems.
• Purchase all necessary supplies for QC Microbiology, author item numbers and material specification documents, order supplies, and receive supplies while logging and storing them according to procedures.
• Perform growth promotion analyses on all microbiological media lots, report results on appropriate forms, and review peers’ results.
• Inspect and clean the laboratory and its equipment on a regular basis.
• Record all necessary information and maintain current, accurate, legible records of all work performed; report problems to management.
• Author and review QC documents, method validation documents, test methods, results, and summary reports for compliance with testing specifications and procedures.
• Track, trend, analyze, and present Environmental Monitoring data via reports and presentations of Change Controls, Deviations, Investigations, and CAPAs to evaluate their potential impact on analytical results and product quality.
• Complete and author reports for various risk assessments related to QC Micro activities for individual products and processes.
• Lead, compose, and present environmental monitoring action committee slides and material on a monthly basis.
• Support tech transfer of microbiological methods into QC.
• Maintain up‑to‑date knowledge of emerging regulations related to QC facilities and operations.
• Ensure a safe work environment.
• Support the development, qualification, validation, and implementation of microbiological development assays when directed by the QC Microbiology Director.
• Ensure compliance with all quality requirements to meet audit standards and regulatory compliance.
• Assist in training staff on methods and related SOPs.
• Lead, participate in, and coordinate risk assessments and EMPQ activities for manufacturing areas, including setting up labs, performing EMPQ studies, and constant monitoring & troubleshooting.
• Perform sample management tasks, including labeling, shipping to external labs, inventory, and disposal of samples.
• Author and maintain critical site documentation, including contamination control strategy, environmental monitoring program, and utility monitoring program.
• Effectively communicate and present department activities via quarterly quality…