Senior Microbiology Lab Lead – GMP & QA Focus

Alora Pharmaceuticals, LLC.; Fort Worth (TX); On-site; USD 95,000 - 130,000; Full time

Job summary

Alora Pharmaceuticals, LLC. seeks a Microbiology Supervisor to lead the microbiology laboratory and ensure timely testing of raw materials, finished products, and stability samples. The role includes acting as stand-in approver when the Microbiology Manager is out.

The supervisor will train staff, supervise testing methods (USP, EM, water testing), review records, and coordinate equipment maintenance to support cGMP compliance and quality systems.

Qualifications

• Bachelor's degree in microbiology, biology, or related field or equivalent experience.
• 7–10 years of experience in a pharmaceutical microbiology laboratory.
• Knowledge of cGMP/GLP/GDP, USP/EU regulatory requirements.
• Experience performing microbiological testing / environmental monitoring using aseptic techniques.
• Excellent technical writing, project management, and organizational skills.

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 management on microbiology testing and related activities.
• Approve/review microbiology test records and logbooks.
• Maintain and coordinate equipment maintenance, calibration, and repair work.

Skills

Technical writing

Project management

Interpersonal communication

Organizational skills

Education

Bachelor's degree in microbiology, biology, or related scientific field or equivalent experience

Job description

Alora Pharmaceuticals, LLC. seeks a Microbiology Supervisor to lead the microbiology laboratory and ensure timely testing of raw materials, finished products, and stability samples. The role includes acting as stand-in approver when the Microbiology Manager is out.

The supervisor will train staff, supervise testing methods (USP, EM, water testing), review records, and coordinate equipment maintenance to support cGMP compliance and quality systems.