Microbiologist II

Role Overview

This role centers on executing quality control activities to guarantee product safety and regulatory adherence within a pharmaceutical manufacturing setting.

Key Responsibilities

• Conduct microbiological assays including bioburden, endotoxin analysis, microbial enumeration, Gram staining, and growth promotion testing on raw materials, intermediate, and finished products.
• Manage submission of samples to third-party laboratories and maintain laboratory inventory levels.
• Design, optimize, and validate microbiological testing protocols; author test protocols, evaluate testing data, and compile comprehensive reports.
• Update Standard Operating Procedures (SOPs), testing methods, and laboratory procedures to ensure alignment with regulatory requirements.
• Engage in validation processes associated with aseptic manufacturing techniques and facilitate environmental monitoring within cleanroom facilities.
• Analyze high-purity water samples, review environmental plates, and conduct microbial identification as necessary.
• Contribute to data analysis, trending efforts, report creation, and instruct new laboratory staff.
• Maintain strict compliance with FDA regulations and current Good Manufacturing/Laboratory Practices (cGMP/cGLP) documentation standards.
• Support aseptic process simulations, sterilization protocols, and tests for container integrity.

Qualifications & Skills

• Bachelor's degree in Microbiology or a related discipline, complemented by 2 to 4 years of relevant industry experience.
• Capability to work independently with effective prioritization of duties.
• Excellent organizational, communication, and interpersonal skills.
• Familiarity with Microsoft Office suite and ability to comprehend technical documentation.
• Physical capacity to wear personal protective equipment (PPE), handle laboratory materials, and lift items weighing up to 25 pounds.