Kevin Kirsch Email and Phone Number

Provide on-site Quality Assurance support for Bristol-Myers Squibb, Indiana Technical Operations, Manufacturing and Packaging operationsEvaluate facility practices to ensure compliance versus current guidelines and policiesConduct, document, and approve investigations (Quality Events) into product and production incidentsWork in cooperation with all levels of personnel in Production and support functions to analyze quality issues, identify root cause through investigation, appropriate disposition of product, and determine corrective/preventative action plansEvaluate and communicate trends and recommend new policies and procedures to maintain complianceConduct weekly Pre-Operational inspections of all manufacturing and packaging areas to ensure site GMP complianceConduct line purge audits to ensure no materials exist from previous campaignsProvide off-shift support with minimal supervisionAttend training events including Root Cause Analysis, cGMP, Safety, Lean Manufacturing, SAPPerform Annual Product Quality Reviews (APQR) of designated productsCalculate and distribute monthly Quality Event metric informationPerform and assist in special projects as requestedPerform and assist in Manufacturing Batch Record (MBR) assessmentsObserve, participate, and provide QA support in external (FDA, EU, etc.) and internal audits of facilities and vendorsBe familiar with 21 CFR Parts 11, 210, and 211 to ensure compliance in daily operationsReview production batch records and release productReview Certificate of Analysis and Certificate of Compliance documentation

Perform microbiological testing, sampling, and media preparationPerform environmental testing in pilot plant and designated manufacturing areasPerform chemical testing through distillation, extraction, dilution, and other techniquesHPLC analytical testing in Chromatographic Vitamin Analysis laboratoryPerform calculation, calibration, standardization, and assays for standardized methodsAttend any training events such as Atlas, LIMS, SAP, Quality month, Safety

Personal Trainer and Fitness FloorPerform personal training by individual appointmentPerform personal training through small group interactionPerform fitness assessments, gym orientations, and continuous feedbackTrain individuals to determine and achieve specific exercise and diet goalsGain sales experience by building clientele through personal training sales and promoting fitness

-Completed 400 hours of internship activities in the Cardiac and Pulmonary Rehabilitation Outpatient area-Managed patient charts, including RPE, blood pressure, pulse, blood oxygen concentration, blood glucose, respiration rates-Utilized patient care techniques to keep patients motivated-Assisted in exercise prescriptions for new incoming patients-Observed various surgeries leading up to rehabilitation-Participated in programs geared towards ongoing commitments for improved lifestyles after rehabilitation was complete

-Completed 300 hours as an intern in Corporate Wellness for the hospital-Created incentive programs for hospital employees and other members of the wellness program-Managed exercise and fitness facilities for the campus-Provided personal training and appropriate exercise techniques for individuals-Lead instructional and practical classes for personal fitness and wellness-Maintained advertisement boards and community boards with applicable fitness and wellness information for the general community across the campus