Erin Bye Email and Phone Number
Erin Bye work email
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Erin Bye personal email
Skilled in implementing and managing electronic Quality Management Systems (eQMS), I bring expertise in document control, training programs, and driving continuous improvements in quality processes. I am passionate about developing robust and proactive systems that enhance efficiency and prevent future non-conformances, ensuring compliance and operational excellence.With in-depth knowledge of ISO 13485, ISO 9001, 21 CFR 820, 210, and 211, I am committed to fostering a culture of compliance and innovation in the medical device and pharmaceutical industries. A fast learner and problem-solver, I strive to leverage my skills to support organizations in delivering safe, high-quality products to the market.
Insulet Corporation
View- Website:
- myomnipod.com
- Employees:
- 4250
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Senior Quality Systems AnalystInsulet CorporationDenver, Co, Us
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Quality System Specialist Ii/IiiTrisalus Life Sciences Sep 2022 - PresentWestminster, Colorado, Us• Spearheaded Veeva Vault (eQMS) cloud platform implementation companywide, responsible for all controlled configuration management, validation, and internal IT support• Responsible for document/change control, author software validation, SOPs, quality plans, reports, etc.• Develop and deliver training materials and facilitate training sessions, manage training companywide • Manage Approved Supplier List and supplier score cards• Drive CAPA investigations to closure through root cause analysis and correction implementation• Investigate nonconformances through NCR process• Conduct internal audits and coordinate backroom activities for third party audits• Produce and analyze quality metrics and implement improvements to ensure KPIs are met• Continuously enhance Veeva Vault functionality• Utilize Vault Loader to import documents, data, and records• ISO 13485, 21 CFR 820, 21 CFR 210, 21 CFR 211 -
Quality Control AssociateInvitae Feb 2021 - Sep 2022San Francisco, Ca, Us• Project Management from laboratory relocation to process improvements• Investigated and document Non-conformances documentation, delivered targeted training materials • Identified and integrated new parts/suppliers, implemented KANBAN system for inventory control• Cross-functional collaboration: planned/implemented engineering change orders, improve processes, etc.• Proficient in authoring of technical SOPs, reports, validations, etc.• Managed stability study samples and equipment, ensured timely testing and maintenance• Acted as backroom representative for internal and external audits• Completed in-depth Root Cause Analysis and LEAN training courses to drive continuous improvement -
Laboratory ManagerUcann May 2020 - Nov 2020Highlands Ranch, Co, UsManaged a small team of technicians and scientists. Oversaw all potency testing at each step in molecule isolation via HPLC, product formulation, and client communication. Worked cross-functionally to develop timelines to determine product deliverability based on production/testing schedules. Streamlined and enhanced safety in formulation processes. -
Quality Assurance ManagerUcann Apr 2019 - May 2020Highlands Ranch, Co, UsEnsured quality and integrity in all testing via HPLC and product formulation. Formulated various topical and consumable products following cGMP standards. Collaborated with ISO 9001 facility to coordinate product shipment and formulation. Created batch tracking documents to track formulations from start to finish and implemented system for intake of client samples.
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Laboratory Technician / Lead Laboratory TechnicianUcann Apr 2018 - Apr 2019Highlands Ranch, Co, UsProficient in HPLC operation and analysis via botanical sample testing. Performed routine maintenance on instrument and troubleshot errors upon occurrence. Authored and maintained SOPs and administered training to technicians. Communicated HPLC analysis results to clients.
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Research AssistantOklahoma State University Aug 2017 - Nov 2017Assisted doctoral student with collared lizard (Crotaphytus collaris) study focusing precocial sexual selection. Performed fieldwork identifying lizards and entering data, proficient in noosing method of lizard capture. Attended behavioral trials and fed lizards in the lab. IUCAC certified.
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Keeper InternTanganyika Wildlife Park May 2016 - Aug 2016Goddard, Kansas, UsTanganyika Wildlife Park is an interactive zoo that provides a unique, immersive experience for guests. Assisted keepers with daily duties such as feeding, food preparation, and cleaning routines. Provided customer service and ensured both patrons and animals were safe during encounters. Created enrichment items for animals and aided in the construction of the penguin exhibit. Attended an animal training course. Accustomed to working in hot and sometimes uncomfortable environments.
Erin Bye Skills
Erin Bye Education Details
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Oklahoma State UniversityGeneral -
Oklahoma State UniversityMinor: Zoology/Animal Biology
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My Vinyasa Practice, LlcYoga Teacher Training/Yoga Therapy
Frequently Asked Questions about Erin Bye
What company does Erin Bye work for?
Erin Bye works for Insulet Corporation
What is Erin Bye's role at the current company?
Erin Bye's current role is Senior Quality Systems Analyst.
What is Erin Bye's email address?
Erin Bye's email address is er****@****ate.edu
What schools did Erin Bye attend?
Erin Bye attended Oklahoma State University, Oklahoma State University, My Vinyasa Practice, Llc.
What skills is Erin Bye known for?
Erin Bye has skills like Microsoft Office, Customer Service, Animal Care, Teamwork, Customer Focused Service, Food Safety, Oganization, Leadership, Time Management, Public Speaking, Organic Chemistry, Biology.
Who are Erin Bye's colleagues?
Erin Bye's colleagues are Luca Peirce, Mark Cole, Raja Alif Fikri, Nelly Quino Hernández, Jean Healy, Daryl Cabrera, Steve Bubrick.
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