We are seeking a highly skilled and detail-oriented 503B QC Chemist to join our team at FarmaKeio Outsourcing, an FDA-registered 503B outsourcing facility. The QC Chemist will be responsible for ensuring the quality, safety, and efficacy of compounded pharmaceuticals by performing a variety of testing and quality control activities. This role is critical in supporting compliance with cGMP (current Good Manufacturing Practices) and other regulatory requirements specific to the compounding industry. Responsibilities: Quality Control Testing: • Perform analytical testing of raw materials, in-process samples, and finished compounded products, including but not limited to potency, sterility, endotoxin levels, and stability. • Ensure compliance with 503B FDA guidelines, USP standards, and internal SOPs (Standard Operating Procedures). Documentation and Record Keeping: • Review and maintain accurate records of test results, batch records, and other required documentation to ensure traceability and compliance. • Prepare and review other regulatory documents for finished products. Method Validation & Development: • Assist in the development and validation of analytical methods for product testing, ensuring they meet all regulatory requirements. • Evaluate new technologies and methods to enhance testing capabilities and improve quality control processes. Compliance and Audits: • Support internal and external audits, inspections, and investigations by providing necessary documentation and test results. • Assist in reviewing and maintaining SOPs to ensure they align with current regulatory standards. Troubleshooting and Investigation: • Identify and troubleshoot issues related to testing, equipment, or products. • Investigate and report any deviations or out-of-specification (OOS) results and assist in CAPA (Corrective and Preventive Action) processes. Equipment Maintenance and Calibration: • Oversee the calibration and maintenance of laboratory equipment and instrumentation to ensure accurate results. • Perform routine troubleshooting and validation of laboratory instruments. Cross-Department Collaboration: • Work closely with Production, Quality, and Fulfillment teams to ensure alignment of product quality standards and testing requirements. Safety and Cleanliness: • Adhere to safety guidelines and maintain a clean and organized lab environment. • Ensure compliance with safety standards for the handling of chemicals and hazardous materials. Qualifications: Education: • Bachelor’s degree in Chemistry, Pharmaceutical Sciences, or a related field. • Master’s degree or higher in a relevant field is a plus. Experience: • Minimum of 2-3 years of experience in a Quality Control or Analytical Chemistry role, preferably within a 503B pharmacy, pharmaceutical manufacturing, or related industry. • Familiarity with USP, FDA 503B guidelines, and cGMP regulations. • Experience with laboratory instrumentation. Skills and Abilities: • Strong analytical and problem-solving skills. • Excellent attention to detail and accuracy in documentation. • Proficient in using laboratory software and instrumentation. • Strong communication skills (both written and verbal) and the ability to work effectively in a team environment.

• Quality Control Testing: • Perform analytical testing of raw materials, in-process samples, and finished compounded products, including but not limited to potency, sterility, endotoxin levels, and stability. • Ensure compliance with 503B FDA guidelines, USP standards, and internal SOPs (Standard Operating Procedures).Documentation and Record Keeping: • Review and maintain accurate records of test results, batch records, and other required documentation to ensure traceability and compliance. • Prepare and review other regulatory documents for finished products.Method Validation & Development: • Assist in the development and validation of analytical methods for product testing, ensuring they meet all regulatory requirements. • Evaluate new technologies and methods to enhance testing capabilities and improve quality control processes.Compliance and Audits: • Support internal and external audits, inspections, and investigations by providing necessary documentation and test results. • Assist in reviewing and maintaining SOPs to ensure they align with current regulatory standards.Troubleshooting and Investigation: • Identify and troubleshoot issues related to testing, equipment, or products. • Investigate and report any deviations or out-of-specification (OOS) results and assist in CAPA (Corrective and Preventive Action) processes.Equipment Maintenance and Calibration: • Oversee the calibration and maintenance of laboratory equipment and instrumentation to ensure accurate results. • Perform routine troubleshooting and validation of laboratory instruments.Cross-Department Collaboration: • Work closely with Production, Quality, and Fulfillment teams to ensure alignment of product quality standards and testing requirements.Safety and Cleanliness: • Adhere to safety guidelines and maintain a clean and organized lab environment. • Ensure compliance with safety standards for the handling of chemicals and hazardous materials.