Quality Control Microbiologist Supervisor

Job Overview
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.

Key Responsibilities:

· 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.

· Ability to perform work while fully gowned within the clean room environment of the gene therapy production facility. To include environmental and utility monitoring including operational and personnel monitoring during aseptic processing and aseptic 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 needed for QC Microbiology. Author item number and material specifications documents and order supplies. Receive supplies, log-in and store appropriately according to written procedures

· Perform growth promotion analyses on all microbiological media lots received. Report results on appropriate forms and review results of peers

· 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 and results, and summary reports, quarterly and annual reports, for compliance with testing specifications and procedures.

· Track, trend, analyze, and present Environmental Monitoring data via report and presentations of Change Controls, Deviations, Investigations and CAPAs and evaluating their potential impact on analytical results and product quality.

· Completes and authors reports for various risk assessments related to QC Micro activities related to individual products and processes.

· Lead, compose, and present environmental monitoring action committee slides and material on a monthly basis.

· Supporting tech transfer of microbiological methods into QC.

· Maintaining an up-to-date knowledge of the new and emerging regulations related to QC Facilities and operations.

· Ensuring a safe work environment.

· Support the development, qualification, validation, and implementation of microbiological development assays when directed by the QC Microbiology Director.

· Ensure compliance to 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 to include: setting up labs, performing EMPQ's, constant monitoring & trouble shooting.

· Perform sample management tasks, including labelling, shipping to external labs, inventory and disposal of samples.

· Author and maintain critical site documentation including site contamination control strategy, environmental monitoring program and utility monitoring program.

· Effectively communicates and presents department activities via quarterly quality metric review meeting.

· Provide support for other duties, as assigned by management.

· Approve employee timesheets and conduct performance evaluations and performance management activities.

· Excellent written, verbal, organizational, and interpersonal communication skills.

· Demonstrated ability to work independently, manage multiple priorities, and collaborate effectively in a cross-functional GMP environment.

Educational Qualifications

· Required: Bachelor's degree in Biology, Microbiology, Biotechnology, Biochemistry, Molecular Biology, Chemical Engineering, Biomedical Engineering, or another related scientific discipline.

· Master's degree in a scientific discipline, preferred.

Additional Qualifications

· Minimum of five (5) years of relevant experience in QC Microbiology, Microbiology, Biologics Manufacturing, Cell Therapy, Gene Therapy, Pharmaceutical Manufacturing, or a related GMP-regulated environment.

Physical Requirements

medium work (< 50 lbs.) heavy work (< 100 lbs.)

Physical activity:

repetitive motion balancing stooping lifting

climbing kneeling/crouching crawling reaching

standing typing/grasping walking pushing/pulling

· Visual acuity (preparing/analyzing data, transcribing, reading, use of measuring devices, machinery labels, color differentiation, etc.)

· Working conditions (indoor/outdoor, noise levels, hazards, working quarters)

Travel Requirements (0%)

Supervisor Responsibilities

· This position requires previous supervisory experience.

US FDA Code of Federal Regulations (CFR) 21