Quality Control Microbiologist Supervisor

Valid8 Financial, Inc.; Town of Florida (NY); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

401(k)

401(k) matching

Employee assistance program

Flexible spending account

Health insurance

Health savings account

Life insurance

Paid time off

Parental leave

Vision insurance

Job summary

Ascend Advanced Therapies is looking for a Quality Control Microbiologist Supervisor to manage testing and compliance with QMS policies and regulatory requirements. The role involves overseeing microbiological testing of drug substances and products while ensuring adherence to GMP standards.

The ideal candidate should have a Bachelor’s degree in a relevant scientific field and over 5 years of experience in a QC Micro role within GMP-regulated environments. Benefits include health insurance and 401(k) matching.

Qualifications

• 5+ years of relevant experience in QC Microbiology or GMP-regulated environment.
• Strong understanding of quality requirements for regulatory compliance.
• Ability to analyze and present data effectively.

Responsibilities

• Perform testing in compliance with QMS policies and procedures.
• Conduct microbiological testing of drug substance and products.
• Author and maintain critical site documentation for QC Micro activities.

Skills

Quality Control Microbiology

GMP Compliance

Microbiological Testing

Environmental Monitoring

Laboratory Equipment Management

Education

Bachelor’s degree in a related scientific discipline

Master’s degree in a scientific discipline (preferred)

Job description

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.
• 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 metric review meetings.
• Provide support for other duties as assigned by management.
• Approve employee timesheets and conduct performance evaluations and performance management activities.

Educational Qualifications

• Required: Bachelor’s degree in Biology, Microbiology, Biotechnology, Biochemistry, Molecular Biology, Chemical Engineering, Biomedical Engineering, or another related scientific discipline.
• Preferred: Master’s degree in a scientific discipline.

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

• 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% travel.

Benefits

• 401(k)
• 401(k) matching
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Vision insurance

Equal Employment Opportunity

We are an equal opportunity employer and welcome applicants from all backgrounds.