Jenni Chi's Email Addresses & Phone Numbers

📖 Summary

Validation Engineer III @ • Develop and generate validation protocols associated with equipment, systems, and processes • Directly and indirectly support the execution of validation protocols (IQ/OQ/PQ/CVP), including the collection of samples, data, and completes protocol attachments • Directly and indirectly compiles and analyzes validation data and prepares reports • Ensures that Validation management is notified of deviations from protocol criteria, supports the identification root causes and resolutions • Coordinates the scheduling of validation protocol executions and testing with affected departments and personnel; this includes Manufacturing, Quality Assurance/Control, and Maintenance. From May 2013 to Present (2 years 8 months) Validation Supervisor @ • Developed and generated equipment and cleaning validation protocol • Performed the validation and writing the summary report • Performed calibration and scheduling preventative maintenance with outside contractors • Managing schedules with production regarding calibration and validation work • Supervised and reviewed the work of new trainees • Revising and implementing validation procedures, execute validation change controls and oversee documentations From September 2009 to May 2013 (3 years 9 months) Validation Specialist II @ • Developed and generated equipment and cleaning validation protocol • Performed the validation and writing the summary report • Performed calibration and scheduling preventative maintenance with outside contractors • Managing schedules with production regarding calibration and validation work • Revising and implementing validation procedures, execute validation change controls and oversee documentations From November 2001 to September 2009 (7 years 11 months) Validation Engineer/Supervisor @ • Supervised and trained the Process Validation group that consisted of 3 to 4 employees • Reviewed, edited and signed validation protocols and reports • Updating/discussing with management of project status, presenting presentations/training sessions, problem solving and schedule planning  Specific Tasks and Projects included: • Developed a Performance Qualification (PQ) protocol and summary for the fogger machines new disinfectant fogging solution • Executed a PQ validation and generated the summary report on the assembly line that was relocated • Developed a Process Validation (PV) protocol and summary on new medications manufactured (i.e. compounding to filling process) • Generated Revalidation protocols for existing medications due to changes • Executed Cleaning Validation and generated summary reports for the new medications (implementations of the finished validation projects to its corresponding SOP(s)) • Developed PQ protocol and summary report along with executing the PQ for four assembly manufacturing lines (i.e. Uro-Jet assembly line, Dilute-A-Jet assembly line, etc) • Revised the protocol and SOP for the Gamma Dose Audit method, executed the process and generated the summary reports for each category audited • Generated and reviewed all cleaning validation reports initiated • Generated addendums to protocols that need re-validating • Generated summary reports for Filter Validations From May 2000 to November 2001 (1 year 7 months) Validation technician @  Performance of work included: • Wrote protocols and summary reports • Execution of written protocols with group members  Projects included: • Writing Performance Qualification (PQ) protocol and summary report along with executing the PQ for the LOJ assembly lines • Writing Process Validation (PV) for the new Cozzoli machine medications • Data analysis for facility’s stopper oven validation  Collaborated projects included: • Execution of Autoclave and Despatch ovens • Cleaning validation executions • Execution of TOYO molding machine execution From November 1999 to May 2000 (7 months) Bachelor of Science (BS), Biology @ Bachelors of ScienceBachelor of Science (BS), Biology, General @ University of California, Riverside Jenni Chi is skilled in: Validation, Sop, Six Sigma, GMP, Lean Manufacturing, V&V, CAPA, Change Control, Cleaning Validation, Quality System