Role Overview: The 503B Microbiologist will play a key role in our quality control processes, ensuring the sterility and microbiological safety of compounded medications, including hormone pellets and other formulations. You will use your expertise to safeguard the health of patients by performing microbiological testing and ensuring compliance with all regulatory requirements. This position is critical to maintaining the highest standards of care and safety in our operations. We are looking for a 503B Microbiologist who is passionate about quality, safety, and service to join our team. If you are an experienced microbiologist with a heart for ensuring the safety and efficacy of medications, we invite you to be a part of our mission to promote healing and wellness. Why Join Us? • Impact Lives: Your work will directly contribute to the safety and well-being of patients, ensuring they receive the highest-quality compounded medications possible. • A Purpose-Driven Culture: At FarmaKeio Outsourcing, we are not just about business, we are about fulfilling a greater purpose. Our team is dedicated to serving others, making a positive difference in the world, and treating each other with kindness and respect, while serving our customers with superior, quality products. This is an on-site position in Southlake, TX. Mon-Fri 8:30am-5:00pm Responsibilities: Key Responsibilities: • Microbiological Testing: Perform sterility testing, endotoxin testing, microbial limit testing, and environmental monitoring to ensure compliance with 503B and USP and standards. • Quality Assurance Control: Monitor and maintain microbiological quality throughout the compounding and manufacturing processes. Review microbiological test results, identify potential contaminants, and report any findings with clear documentation. • Environmental Monitoring: Conduct routine assessments of cleanrooms and production areas, ensuring that our facility meets and exceeds all cleanliness and sterilization protocols. • Documentation Compliance: Accurately document all microbiological tests, environmental monitoring results, and corrective actions in accordance with cGMP and FDA guidelines. Ensure proper record-keeping for audits and regulatory inspections. • Collaboration: Work closely with other departments such as Production, Quality Control, and Fulfillment to support the overall goals of the company. Act as a resource to educate and train team members on microbiological best practices. • Sterility Assurance: Ensure all procedures, from raw materials to finished products, meet the highest sterility standards to protect patient safety. • Problem Solving Troubleshooting: Identify and resolve microbiological issues in the production process or facility. Offer solutions that align with safety, compliance, and quality assurance. • Continuous Improvement: Stay up to date with microbiological trends, best practices, and changes in regulations. Lead or participate in process improvement initiatives to optimize operations and quality standards. Qualifications: • Education: Bachelor’s degree in Microbiology, Biology, or a related field. A Master’s degree or certification in a specialized microbiological field is a plus. • Experience: Minimum of 3-5 years of experience in a microbiology laboratory setting, preferably in a pharmaceutical or 503B environment. • Knowledge: Solid understanding of microbiological testing methods, sterility assurance, endotoxin testing, and environmental monitoring. Familiarity with regulatory guidelines such as USP and FDA compliance. • Attention to Detail: Strong attention to detail and accuracy in all aspects of testing, documentation, and reporting. • Communication Skills: Excellent written and verbal communication skills with the ability to present complex data clearly and effectively. • Team Player: Ability to collaborate and work effectively with cross-functional teams, bringing a positive and service-minded approach to all tasks. • Compliance Focused: A strong commitment to maintaining regulatory compliance, patient safety, and quality standards. Compensation: $65,000 - $85,000 yearly

• Key Responsibilities: • Microbiological Testing: Perform sterility testing, endotoxin testing, microbial limit testing, and environmental monitoring to ensure compliance with 503B and USP and standards. • Quality Assurance Control: Monitor and maintain microbiological quality throughout the compounding and manufacturing processes. Review microbiological test results, identify potential contaminants, and report any findings with clear documentation. • Environmental Monitoring: Conduct routine assessments of cleanrooms and production areas, ensuring that our facility meets and exceeds all cleanliness and sterilization protocols. • Documentation Compliance: Accurately document all microbiological tests, environmental monitoring results, and corrective actions in accordance with cGMP and FDA guidelines. Ensure proper record-keeping for audits and regulatory inspections. • Collaboration: Work closely with other departments such as Production, Quality Control, and Fulfillment to support the overall goals of the company. Act as a resource to educate and train team members on microbiological best practices. • Sterility Assurance: Ensure all procedures, from raw materials to finished products, meet the highest sterility standards to protect patient safety. • Problem Solving Troubleshooting: Identify and resolve microbiological issues in the production process or facility. Offer solutions that align with safety, compliance, and quality assurance. • Continuous Improvement: Stay up to date with microbiological trends, best practices, and changes in regulations. Lead or participate in process improvement initiatives to optimize operations and quality standards.