Meredith Frederick Email & Phone Number

Wichita, Ks, Us

Wichita, Kansas, United States

Wichita, Kansas Metropolitan Area

Wichita, Kansas Area

• Work cross functionally with all departments (Validation, Environmental Monitoring, Laboratory, Microbiology, Production, Post-Production and Supply Chain) establishing and implementing process improvement objectives and projects in a 503b outsourcing pharmaceutical company that adheres to FDA regulations through cGMP systems.• Work on the manufacturing floor and across the site for data gathering from various sources (audit, interview, observation)• Ensure robustness (complete, accurate and defendable) of all critical and major investigations by performing Root Cause Analysis to determine the most likely cause of the deviation and identification of Corrective and Preventative Actions for recurrence reduction.• Align internal review team and area subject matter experts on an agreed investigational path forward, author investigations and support resolution through experimental DOE and execution. • Implement and track maintain for effectiveness CAPA and process improvement objectives through cGMP systems (e.g. MBR revision, training, etc.).• Act as Aseptic Process Simulation Coordinator on execution of Validation protocols to qualify and validate new processes and requalification for the facility.

Wichita, Kansas Area

• Responsible for cost of production and maintenance activities including process improvement, supply chain management, quality assurance, employee safety and engagement, and environmental commitment.• Responsible for critical and major investigations by performing Root Cause Analysis to and identification of Corrective and Preventative Actions for recurrence reduction. Author or Approver of Quality assurance and radiation safety investigations.• Responsible for the manufacturing of time sensitive ANDA radiopharmaceuticals in an integrity driven, highly regulatedenvironment (i.e. FDA, NRC, DOT) to support patient treatment through disease diagnosis, staging, and monitoring.• Knowledge and familiarity with quality management systems, 503a, 503b, cGMP, EHS, radiation safety regulations and cyclotron theory.• Tasks performed in ISO 7 and ISO 5 certified work environments and equipment (Fumehood, LAFW, Von Gahlen hot cell, TEMA hot cell, and Comecer hot cell) utilizing analytical equipment (HPLC, Manual GC, Automated GC, PTS and EZ-Scanner) and synthesizing equipment TRACERlab MX-FDG.

Columbus, Ohio Area

Columbus, Ohio Area

Sharon Hill, Pa (Nov 2014-Mar 2014) Columbus, Oh (Apr 2015-Aug 2015)

Sharon Hill, Pennsylvania

King Of Prussia, Pennsylvania, United States

Reviewed and edited monthly physicians order forms and telephone orders returned to the pharmacy to input recap notations, non-medication order changes and other information provided relative to medical records and print monthly medical records package for an average 1200 patients.

Philadelphia, Pa

Compounded non-commercially available medications and intravenous simple and complex chemotherapy orders and Total Parental Nutrition orders as well as fill basic pharmacy orders involving tablet/capsule counting, reconstitution of powders, and single dose injection orders