luke stark

luke stark

quality assurance medical device development

About

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, and other life sciences. I spent a year working as a quality engineer for a dietary supplement manufacturer getting to explore hands on experience with preventive maintenance, RO water systems, and other day-to-day activities. In March of 2015, I launched my journey into electronics manufacturing quality.

Country

united states

City

indianapolis

Industry

pharmaceuticals

Skill

cqa, pharmaceutical industry, validation, fda, gmp, capa, medical devices, quality assurance, 21 cfr part 11, quality system, process improvement, technical writing, sop, continuous improvement, lean manufacturing, root cause analysis, manufacturing, quality management, cqe, leadership, computer system validation, change control, testing, gamp, gxp, cleaning validation, iso 13485, u.s. food and drug administration, standard operating procedure, corrective and preventive action

Experience

living essentials

quality engineer

living essentials

2014-1 - 2015-3 · 1 yr 3 mos

I provided quality input in the preventive maintenance process including implementing a computerized maintenance solution to improve PM data gathering and completion. I was given direct responsibility over the operation of a RO Water system ensuring proper operation, maintenance, and general stewardship. Other activities included creating validation testing documents, SOP creation, and general auditing of operations and engineering processes.

performance validation

validation engineer and project leader

performance validation

2005-6 - 2014-1 · 8 yrs 8 mos

I provide validation and qualification activities for pharmaceutical manufacturing systems and data management systems. I also provide insight on how to improve quality systems and how to better enable a client to maintain suitability for their quality system.

eli lilly and company

validation contractor - performance validation

eli lilly and company

2005-1 - 2014-1 · 9 yrs 1 mo

I created: periodic reviews (periodic quality evaluations), quality plans for installing/updating equipment, I create qualification documents to test the suitability of equipment.

rose-hulman institute of technology

student

rose-hulman institute of technology

2001-1 - 2005-5 · 4 yrs 5 mos

I majored in computer engineering. I received a minor in literature and language. I was the Co-Editor-in-Chief of the school newspaper for 2 years.

technicolor

product quality assurance

technicolor

2015-3 - 2016-6 · 1 yr 4 mos

Exploring a new side of quality assurance in electronics. I work with a worldwide team to ensure process driven design and implementation of customer needs. I also provide SPC input to our worldwide manufacturing team to ensure quality criteria are met for product released to the customer.

eli lilly and company

quality assurance medical device development

eli lilly and company

2016-6 - Present · 10 yrs 4 mos

Lilly is a global health care leader that unites caring with discovery to make life better for peoplearound the world. For more than a century, we have stayed true to a core set of values—excellence,integrity, and respect for people—that guide us in all we do: discovering medicines that meet realneeds, improving the understanding and management of disease, and giving back to communitiesthrough philanthropy and volunteerism.

Education

henryville junior - senior high school

henryville junior - senior high school

silver creek high school

silver creek high school

rose - hulman institute of technology

rose - hulman institute of technology

english language

2001-1 - 2005-1 · 4 yrs 1 mo

luke stark's Contact Information

Email

******@***.com

Phone

(**) *** ****

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