As part of the Quality Unit at FarmaKeio Outsourcing (FKO), the Quality Pharmacist assists the Quality Director in overseeing the accuracy and completeness of products manufactured at FKO by establishing/approving documentation and reviewing quality data throughout all units of FKO. This role is responsible for reporting and developing/reviewing documentation to verify proper Quality Management System implementation. The Quality Pharmacist provides direct oversight of the compounding of pharmaceutical products at FKO and shall be responsible for batch approval/rejection since regulations require compounding to be by or under the direct supervision of a licensed pharmacist. Reports to: Quality Director *This is an on-site position in Southlake, TX. Schedule is Monday through Friday. * Responsibilities: Perform and/or coordinate completion of: • Environmental monitoring and documentation e.g. personnel monitoring, air bioburden, surface bioburden, temperatures, and particle counts • Collect environmental monitoring samples as necessary • Train new Quality Unit staff • Record sterility testing results, aseptic technique qualifications, and media fill process validations • Prepare/revise operating procedures and specifications • Review/approve routine change control requests as designated • Verify that raw materials meet specifications limits • Oversee control of product labeling/label accountability • Recommend and/or implement improvements in streamlining processes and procedures in the areas of compounding, validation, change control, laboratory, and risk assessments • Use incident and Corrective and Preventive Action (CAPA) activities and processes to drive quality improvements and respond to process and service issues • Assist with root cause analysis and CAPA for audit observations, product complaints, product non-conformances, in-process deviations, and CAPA • Assist with the investigation of excursions in manufacturing or other related operations. Resolve the cause, impact on product quality, disposition, and corrective actions at the direction of the Quality Director • Perform final review of test data/reports to ensure conformance to the established specifications and standard operating procedures and perform final disposition of batches • Verify that product test results meet specification limits • Track vendor equipment calibration and maintenance records and assess for deviations • Assist the Quality Director with results of deviation and complaint investigations, quality-related events, causal analysis, corrective actions, and preventive actions • Maintain quality records (equipment calibration and maintenance, training, deviation, and complaint investigation, environmental monitoring, Certificate of Analysis, clean room certification) • Reciprocate Pharmacist License as necessary to comply with regulatory requirements Qualifications: • BS Pharmacy or Pharm.D with registration in good standing and current pharmacist license in the state of Texas • Ability to work autonomously within established procedures and practices Work Environment: Climate-controlled office environment Knowledge & Skills • Working knowledge of Current Good Manufacturing Practices (cGMPs), FDA regulations (21 CFR Parts 210, 211), and ICH regulations • Effective communication skills, both written and verbal • Ability to act effectively as a member of a team to resolve problems • Good organizational and time management skills Physical and Special Requirements: • Ability to stand for prolonged periods of time • May need to lift, up to 40 pounds • Limited exposure to potentially hazardous substances Compensation: $120,000 - $140,000 yearly

• Perform and/or coordinate completion of: • Environmental monitoring and documentation e.g. personnel monitoring, air bioburden, surface bioburden, temperatures, and particle counts • Collect environmental monitoring samples as necessary • Train new Quality Unit staff • Record sterility testing results, aseptic technique qualifications, and media fill process validations • Prepare/revise operating procedures and specifications • Review/approve routine change control requests as designated • Verify that raw materials meet specifications limits • Oversee control of product labeling/label accountability • Recommend and/or implement improvements in streamlining processes and procedures in the areas of compounding, validation, change control, laboratory, and risk assessments • Use incident and Corrective and Preventive Action (CAPA) activities and processes to drive quality improvements and respond to process and service issues • Assist with root cause analysis and CAPA for audit observations, product complaints, product non-conformances, in-process deviations, and CAPA • Assist with the investigation of excursions in manufacturing or other related operations. Resolve the cause, impact on product quality, disposition, and corrective actions at the direction of the Quality Director • Perform final review of test data/reports to ensure conformance to the established specifications and standard operating procedures and perform final disposition of batches • Verify that product test results meet specification limits • Track vendor equipment calibration and maintenance records and assess for deviations • Assist the Quality Director with results of deviation and complaint investigations, quality-related events, causal analysis, corrective actions, and preventive actions • Maintain quality records (equipment calibration and maintenance, training, deviation, and complaint investigation, environmental monitoring, Certificate of Analysis, clean room certification) • Reciprocate Pharmacist License as necessary to comply with regulatory requirements