Morgan Millard Email & Phone Number

Lebanon, Indiana, United States

Indianapolis, Indiana, United States

▪ Coordinate and conduct qualification and routine audit of Raw Material, Excipient and API Suppliers using the FDA, EU, JP, and ICH guidelines▪ Coordinate, host, and conduct internal audits to ensure compliance with regulatory requirements and identify opportunities for improvements ▪ Ensure supply chain continuity▪ Manage and review risk assessments associated with materials and suppliers▪ Evaluate and determine categorization of incoming or changed materials used in facility▪ Maintain and update supplier qualification list with products▪ Initiate, investigate, track, and execute CAPAs associated with supplier change notifications and deviations▪ Create decision charts for supplier management SOPs

Indianapolis, Indiana, United States

▪ Responsible for the day-to-day supervision of up to 9 QC Microbiology analysts across different shifts▪ Interview candidates for analyst positions for the department▪ Train new analyst in lab technique and assays▪ Mentor current analyst and bring team building activities to department▪ Responsible for the weekly schedule for the lab and EM responsibilities▪ Attend daily and weekly status meeting to relay updates and communications with team and other departments▪ Work internally and with multiple clients as QC Microbiology representative on project teams▪ Assist and support audits from clients, internal, and safety audits ▪ Initiate, investigate, assess risk, and close non conformances and issues▪ Update and create ACM’s, SOP’s, and forms for new products and to increase efficiency▪ Review ACM’s, SOP’s, ICM’s and protocols to ensure quality and alignment across department documents▪ Review protocols for bioburdens and studies for the department▪ Author protocols for bioburdens and baseline study for department, also authored certificate of analysis for completed media fill▪ Test assays including gel-cot, particulate testing (Microscope and HIAC), biological indicator testing for autoclave validation, container closure testing, and expanded testing roles in KTA▪ Execute product bioburden qualification▪ Sample for environmental monitoring by collecting water, air, and surface samples in controlled environments ▪ Sample environmental monitoring during active filling operations▪ Qualified in aseptic gowning▪ Responsible for trending and reviewing environmental monitoring data, investigating adverse trends and excursions▪ Collaborate with multiple departments to ensure a thorough investigation for excursion events

Indianapolis, Indiana, United States

▪ Author protocols for bioburdens and baseline study for department, also authored certificate of analysis for completed media fill▪ Update and create ACM’s, SOP’s, and forms for new products and to increase efficiency▪ Review ACM’s, SOP’s, ICM’s and protocols to ensure quality and alignment across department documents▪ Initiate, investigate, assess risk, and close NC’s ▪ Attend daily and weekly status meeting to relay updates and communications with team and other departments▪ Work internally and with multiple clients as QC Microbiology representative on project teams▪ Interview candidates for both manager position and analyst positions for the department▪ Increased efficiency in executing product bioburden qualification▪ Perform responsibilities listed below in Analyst I and II positions

Indianapolis, In, United States

▪ Organize and present monthly environmental data to Environmental Action Committee, also when needed for adverse trend events▪ Organize, compile data, author summary report for EMPQ protocols and baseline studies▪ Author quarterly water report and help write/compile data for annual report of the facility▪ Learned additional Assays including gel-cot, particulate testing (Microscope and HIAC), biological indicator testing for autoclave validation, container closure testing, and expanded testing roles in KTA▪ Perform investigational feasibility testing on buffer showing endotoxin masking in KTA ▪ Execute product bioburden qualification▪ Prep plates needing to be sent out for identification▪ Work internally and with a client as QC Microbiology representative on project team▪ Train new analyst in lab technique and assays▪ Mentor current analyst and bring team building activities to department▪ Perform all responsibilities listed below in Analyst I position

Indianapolis, Indiana

▪ Sample for environmental monitoring by collecting water, air, and surface samples in controlled environments▪ EMPQ experience and understanding with new areas ▪ Responsible for trending and reviewing environmental monitoring data, investigating adverse trends and excursions▪ Collaborate with multiple departments to ensure a thorough investigation for excursion events▪ Perform a monthly statistical analysis for all classified areas for presentation of data to Environmental Action Committee▪ Attend PMF environmental summit May 2019 and brought back valuable knowledge to the team▪ Perform media release, organism release, container closure testing, gram staining, endotoxin testing (KTA), media, product fill monitoring, personnel monitoring, MiniCapt Microbial Air protocol, water chemistry testing, and water testing for microbials▪ Experimental designing for method development for disinfectant effectiveness testing▪ Work with autoclaves, pipettes manual and automatic, centrifuge, vortex, manifolds, pumps, water fills, Super 180 Air Sampler, and MiniCapt Microbial Air▪ Qualified in aseptic gowning▪ Responsible for ordering all consumables, media, and equipment for department▪ Responsible for the weekly schedule for the lab and EM responsibilities▪ Perform all functions using aseptic technique and in accordance with SOP’s, ICM’s, ACM’s and GxP guidelines

Indianapolis, Indiana

Indianapolis, Indiana

Evansville, Indiana Area

Evansville, Indiana Area

Evansville, Indiana Area