
Luke Stark
In my first position out of school, I spent 8.5 years learning about life sciences quality systems while... | Indianapolis, Indiana, United States
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Luke Stark’s Emails lu****@li****.com
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Luke Stark’s Location Indianapolis, Indiana, United States
Luke Stark’s Expertise In my first position out of school, I spent 8.5 years learning about life sciences quality systems while working as a consultant (project manager, validation, auditing, etc) in the realm of pharmaceutical and medical device manufacturing. During this time I was able to experience a wide range of clients from large corporations to small laboratories. Learning GxP and risk application of validation and quality principles helped form a solid understanding of quality systems and application of FDA regulatory requirements. I spent a year working as a quality engineer for a dietary supplement manufacturer getting to explore hands on quality engineering with preventive maintenance, RO water systems, and other day-to-day activities. This position leveraged my engineering background and expanded on my understanding of quality. Allowing quality and manufacturing to work together to create product with the least oversight necessary to function. In March of 2015, I launched a journey into electronics manufacturing quality. Working with an international team allowed me to improve my understanding of manufacturing techniques and systems measurements. I was able to implement and improve on the quality metrics used to determine how well the manufacturing site was operating. My improvements to the quality metrics provided a way to understand re-work issues and allowed us to be more aligned with people across the globe. In June 2016, I returned to the life sciences and began a position in medical device development quality assurance. This has leveraged my understanding of quality systems and FDA regulatory requirements. I am concurrently working on process improvement by modernizing and aligning procedures with current practices and technology while being a quality representative on several development teams. I am always learning more about clinical trials, global procurement, contract service providers, contract manufacturers, and transferring devices to manufacturing.
Luke Stark’s Current Industry Eli Lilly
Luke
Stark’s Prior Industry
Rose Hulman Institute Of Technology
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Eli Lilly
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Performance Validation
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Living Essentials
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Technicolor
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Work Experience

Eli Lilly
Senior Principal Associate Quality Assurance, Device Development
Wed Jun 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Technicolor
Product Quality Assurance
Sun Mar 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Jun 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time)
Living Essentials
Quality Engineer
Wed Jan 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Mar 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time)
Performance Validation
Validation Engineer and Project Leader
Wed Jun 01 2005 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Jan 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time)
Eli Lilly
Validation Contractor - Performance Validation
Sat Jan 01 2005 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Jan 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time)
Rose Hulman Institute Of Technology
Student
Mon Jan 01 2001 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun May 01 2005 00:00:00 GMT+0000 (Coordinated Universal Time)