Kristian Ashe
UPS Healthcare QA Manager for Global I.T. Systems
- Role
- Healthcare Q a Associate Manager for Global i t Systems at UPS
- Location
- Roswell, GA, US
- LinkedIn followers
- 500 followers
About Kristian Ashe
Graduated from Emory University with a B.A. in Chemistry. While at Emory University, I had the privilege to intern at the Center of Disease Control for two years. Throughout the years, I\'ve gained 10 years in the GxP Medical Device, Pharmaceutical, and Distribution. Working in validation, I have consulted with internal groups (e.g. operations, business, development, I.T, etc) and investigated and resolved healthcare issues to ensure compliance with FDA, EU, ISO rules and regulations. Provide guidance to IT department to maintain validation of warehouse and/ or support systems utilized for healthcare applications. Additionally, conducted audits and periodic validation reviews of validated systems, processes, and applications. Generate risk assessment, gap analysis, decommissioning and any other form of remediation required to close any open action items as a result of review and audit findings. I have led facility qualifications for new applications and manufacturing facilities, including development of the validation plan, and development and execution of qualification and validation protocols.
Experience
Healthcare Q a Associate Manager for Global i t Systems
May 2020 — Present · Alpharetta, GA, US
Manage and advise supply chain concepts and risk management fundamentals. Familiarized in new European Medicines Verification System (EVMS) and National Verification Medicines System (Directive on Falsified Medicines 2011/62/EU). Created validation master plans and oversaw audits and validation work for supportive applications, like WebOps, Docusign, Kneat, and various Automation Framework. Apply established procedures for responding incidents; determine and document information pertinent to incidents; and communicates resolutions and all results to stakeholders.
Education
Emory University
Bachelor's degree, Chemistry
2004 — 2008
Skills
- Protein Chemistry
- Gas Chromatography
- Western Blotting
- Spectroscopy
- Purification
- Fluorescence
- Pcr
- Quality System
- Microsoft Office
- Elisa
- Uv/Vis
- Quality Assurance
- Microscopy
- Nmr
- Validation
- Mass Spectrometry
- Biochemistry
- Medical Devices
- Capa
- Gel Electrophoresis
- Hplc
- Column Chromatography
- Quality Control
- Gmp
- Analytical Chemistry
- Sop
- Fda
- Chromatography
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.