Celeste Birmingham Email & Phone Number

Houston, Tx, Us

United States

Develop new manufacturing procedures and analytical methods. Support the development, writing, and updating of protocol documentation. Perform process validation activities. Maintain aseptic operations and FDA regulations in compliance with USP <797>, <823>, proposed <825> regulations, and other state pharmacy requirements. Conduct aseptic techniques and perform sterile manufacturing activities within a GMP and ISO environment. Sustain a clean and safe work area using the 6S principles. Manufacture diagnostic and therapeutic radionuclides and drug products such as Ga68-PSMA and Ac225-PSMA. Document all activities to meet cGMP requirements for review. Identify critical and minor deviations, aid in investigations, root cause analysis, product impact, and corrective/preventative actions (CAPAs) in manufacturing procedures. Understand and apply thorough quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP). Drive change controls and gap analysis improvements. Perform internal and external audits. Conduct radiation safety responsibilities and site licensing requirements. Perform radiation safety by performing wipes, surveys, and linearities. Perform equipment Operational Qualifications / Performance Qualifications (OQ/PQs). Utilize PETRA – LIMS system software to use for manufacturing and quality control inventory management documentation.

United States

As an SMO, I execute aseptic technique and sterile compounding in an ISO classifiedcGMP setting while committing to comply to all required hygienic practices and garbingper company policy. Supports with sterilization of materials and devices used for thecompounding processes via ISO5 Classified disinfectants, Autoclave, andDecontamination Chamber. Maintain additional tasks to aid the accomplishment of theproduction schedule and daily compounding processes using prioritization andorganizational skills. Effectively calculates and completes sterile product documentationfollowing protocol of Good Manufacturing Practices. Proficient with Microsoft 365 OfficeApps. Cooperate with special projects. Assists with guiding new hires to the steriledepartment and company SOPs and guidelines.

Houston, Texas, United States

As the lead technician in pharmaceutical compounding, my priorities revolve around positive team morale and high production success percentage. With my expertise in detail orientation and organization, refining the weekly technician schedule, effective technician training, improving numerous of manufacturing processes, and production management aided the goal of 100% daily production completion 70% of the week contributing to dispensing medication on-time to patient's progression. Specializing in chemical usage and inventory management required maintenance with supporting documentation to advance the efficiency of chemical necessity and inventory operations to sustain the daily compounding production. Regulating daily waste documentation to account for production demands and schedules to maintain supply levels to minimize the amount of chemical and product waste consumption. With significant results of 85% to 100% of products produced being wasted to less than 20% of the products going to waste which led to monetary and timely savings.

Texas, United States

By assisting the RPh on duty, I conduct the workflow of the pharmacy by organizing the destination of pharmacy items and supervising the work of other technicians. Responsible for medication and product ordering. Efficiently entering patient and prescription data, dispensing medication precisely, and shipping prescription packages on time. Receive and check in drug orders.

Sugar Land, Texas, United States

As the CPhT, outstanding performance was proven with data-entry, efficient production, patient calls, doctor calls and on-time prescription deliveries were finalized at a due time. Prepared non-sterile compounds including the calculations to create the compound formula. Submitted prior authorization forms for specialty and non-specialty drugs to insurances. Executed the medication synchronization through the Pioneer RX Software from the start to 80% of the patients being synced within a 4-month span. Progressed the reordering, restocking, and organizing the OTC items and pharmacy supplies. In transportation management I productively managed a team of 10 contract drivers scheduling daily shifts to each individual and routing scheduled deliveries based off distance and timeframe. Regulated the scheduled deliveries via Microsoft Teams and MapQuest. Accurately processed and submitted each driver’s mileage and payroll biweekly via Excel and ADP. Performed a bi-weekly company vehicle exterior inspection, scheduled all state inspections, vehicle services, and supervised the company gas credit card. Conducted a few written policies to ensure the protocol of all rules and regulations for everyone performing these duties.

Willis, Texas, United States

As the CPhT Shift Supervisor, I’ve accomplished structured pharmacy tasks, such as data entry, insurance billing, doctor calls and filling various medications. Proper sanitation and cleaning. Hardcopy prescription filing. Completed control substance weekly counting. Utilized medication-synchronization for the pharmacy. Compelled flu-shots and participated in a few flu-shot clinics. Cash handling and paperwork during opening and closing periods. Performed product and vendor check-ins and executed the product replenishment. Trained new employees. Accomplished seasonal planograms and American Greetings card ordering and display.