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

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

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

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

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

Indianapolis, Indiana

Indianapolis, Indiana

Evansville, Indiana Area

Evansville, Indiana Area

Evansville, Indiana Area