503B Microbiologist

Farmakeio Outsourcing • Southlake, TX

398d • $65,000 - $85,000

About The Position

The 503B Microbiologist at FarmaKeio Outsourcing is responsible for ensuring the sterility and microbiological safety of compounded medications. This role is critical in maintaining quality control processes and compliance with regulatory standards, directly impacting patient safety and well-being. The position requires a dedicated professional with a strong background in microbiology to perform various testing and monitoring tasks, collaborate with cross-functional teams, and contribute to continuous improvement initiatives.

Requirements

• Bachelor's degree in Microbiology, Biology, or a related field.
• Minimum of 3-5 years of experience in a microbiology laboratory setting, preferably in a pharmaceutical or 503B environment.
• Solid understanding of microbiological testing methods, sterility assurance, endotoxin testing, and environmental monitoring.
• Familiarity with regulatory guidelines such as USP and FDA compliance.
• Strong attention to detail and accuracy in testing, documentation, and reporting.
• Excellent written and verbal communication skills with the ability to present complex data clearly and effectively.
• Ability to collaborate and work effectively with cross-functional teams.

Nice To Haves

• Master's degree or certification in a specialized microbiological field is a plus.

Responsibilities

• Perform sterility testing, endotoxin testing, microbial limit testing, and environmental monitoring to ensure compliance with 503B and USP standards.
• Monitor and maintain microbiological quality throughout the compounding and manufacturing processes.
• Review microbiological test results, identify potential contaminants, and report findings with clear documentation.
• Conduct routine assessments of cleanrooms and production areas to ensure cleanliness and sterilization protocols are met.
• Accurately document all microbiological tests, environmental monitoring results, and corrective actions in accordance with cGMP and FDA guidelines.
• Collaborate with other departments such as Production, Quality Control, and Fulfillment to support overall company goals.
• Act as a resource to educate and train team members on microbiological best practices.
• Ensure all procedures meet the highest sterility standards to protect patient safety.
• Identify and resolve microbiological issues in the production process or facility, offering solutions that align with safety, compliance, and quality assurance.
• Stay up to date with microbiological trends, best practices, and changes in regulations, leading or participating in process improvement initiatives.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree