Senior Microbiology Lab Supervisor - GMP & Validation

Avion Pharmaceuticals, LLC; Fort Worth (TX); On-site; USD 90,000 - 140,000; Full time

Job summary

Avion Pharmaceuticals, LLC is seeking a Microbiology Supervisor to lead the microbiology laboratory in daily activities, ensuring raw materials, finished products, stability samples, and research batches are tested within required timeframes.

The role includes training, approving records, maintaining calibration, coordinating media and supplies, and ensuring compliance with GMP, GLP, USP, and regulatory audits, with hands-on leadership of the team on 1st shift.

Qualifications

• Bachelor's degree in microbiology, biology, or related field.
• 7–10 years of experience in a pharmaceutical microbiology laboratory.
• Knowledge of cGMP/GLP/GDP and USP/EU regulatory requirements.
• Experience with microbiological testing and environmental monitoring using aseptic techniques.
• Strong technical writing, project management and organizational skills.
• Experience with regulatory audits.
• Experience handling biohazardous materials.
• Qualified to work with controlled substances.

Responsibilities

• Adhere with SOPs and regulatory requirements such as GMPs, GDPs, GLPs and OSHA regulations.
• Direct training as the subject matter expert of all microbiologists and maintain training documents.
• Update the Associate Director of Quality Systems / Microbiology, QA and other plant management on microbiology testing and related activities.
• Approve/review microbiology test records and logbooks.
• Maintain and coordinate equipment/instrumentation maintenance, calibration, and repair work.
• Contact media and supply vendors to troubleshoot issues.
• Schedule and approve scheduled time off by microbiologists.
• Schedule and ensure microbiology activities are performed promptly and compliantly.

Skills

Technical writing

Project management

Communication skills

Organizational skills

Interpersonal communication

Controlled substances handling

Regulatory knowledge

Audits experience

Education

Bachelor's degree in microbiology or related field

Tools

VITEK ID System

VITEK 2 Compact Isolate Identification System

Job description

Avion Pharmaceuticals, LLC is seeking a Microbiology Supervisor to lead the microbiology laboratory in daily activities, ensuring raw materials, finished products, stability samples, and research batches are tested within required timeframes.

The role includes training, approving records, maintaining calibration, coordinating media and supplies, and ensuring compliance with GMP, GLP, USP, and regulatory audits, with hands-on leadership of the team on 1st shift.