Michelle Steffens Email and Phone Number
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20+ years of experience in the pharmaceutical and medical device industry. Ranging from R&D, operations and Quality. Experience in product design, risk management, on-market technical support, operations, supplier quality, auditing, operations quality, analytical test method development, validation and troubleshooting. Audit existing suppliers and prospective suppliers to 21CFR820, 600, 606, 610, 640, part 11, part 50 and 56, GCP regulations, ISO:9001, 13485 and 17025, ICH Guidelines and other global quality standards.Specialties: on-market technical support, design control, risk management, operations, supplier quality, test method validation, validation & verification and troubleshooting. Quality systems, operations quality, auditing, Lean Six Sigma, supplier control, CAPA, quality plans, quality agreements, service agreements and regulatory submissions.
Baxter International Inc.
View- Website:
- baxter.com
- Employees:
- 24782
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Director Medical Products & Therapies Project ManagementBaxter International Inc. Jun 2023 - Present
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Associate DirectorBaxter Healthcare Corporation Mar 2022 - PresentUnited States -
Senior ManagerBaxter Healthcare Corporation Aug 2018 - Mar 2022Deerfield, IlSr Manager of Renal Solutions R&D Peritoneal Dialysis Sustaining Products team. Providing on-market technical, design and risk management support for Peritoneal Dialysis products world-wide. A global team comprised of 10 individuals (BS to PhD) that support 15+ global manufacturing plants.
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Research Scientist IiBaxter Healthcare Oct 2014 - Jul 2018Round Lake, IlResearch Scientist II - Sustaining Product Operations. Provide technical support for on market, world-wide drug products. Duties include product design management, management of design history files, creation and management of risk management files, technical and product support to global manufacturing plants, regulatory bodies, health care providers and patients.
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Manager 1 Supplier QualityBaxter Healthcare Corporation Sep 2012 - Oct 2014Corporate supplier quality manager for prospective supppliers of drugs, biologics, medical devices or services. Interface with regulatory bodies, continuous improvement projects, quality assessments of internal operations and suppliers to analyze compliance and risk, implementation and maintenance of quality procedures.
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Qa Consultant Lvl IiAbbott Diagnostics Aug 2009 - Aug 2012Oversight of suppliers of purchased raw materials (chemicals, biologics, commodities) and services. Issuance of CAPA, review/approval of CAPA, quality agreements, action plans, service agreements and metrics. Maintenance of quarterly sterility dose audit program, gamma irradiation subject matter expert, served on Divisional CAPA board and owner of global CAPA for site. -
Qa Manager, Incoming QualityAbbott Laboratories Jul 2005 - Aug 2009Managed an annual budget of $2.2 million dollars including a multi-displinary team of over 20 individuals of differing skill levels. Managed the incoming inspection and disposition of purchased chemicals, biologics, commodities and third party manufactured final product kits. Sponsored a lean six sigma project that reduced backlogs by 90% and cycle time from 30 days to 7 days.
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Qa SupervisorAbbott Laboratories Jan 2003 - Feb 2006QA Supervisor of 15 direct reports responsible for the lot release testing of rare reagents for diagnostic assays. Increased work efficiency of the area from 65% on time to greater than 90% ontime. Acquired my ASQ Quality Manager certification.
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Senior Scientist, Core R&DAbbott Laboratories Jul 1999 - Jan 2003Responsible for the development and validation of analytical test methods to be used for the lot release testing of rare reagents utilized in diagnostics assays. Major accomplishment was validating over 40 codes in Gel Permeation chromatography in under 6 months utlizing a common test method approach and successfully transferred the method to the end user laboratory.
Michelle Steffens Skills
Michelle Steffens Education Details
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Applied Molecular Biology
Frequently Asked Questions about Michelle Steffens
What company does Michelle Steffens work for?
Michelle Steffens works for Baxter International Inc.
What is Michelle Steffens's role at the current company?
Michelle Steffens's current role is Director Medical Products & Therapies Project Management.
What is Michelle Steffens's email address?
Michelle Steffens's email address is mi****@****ott.com
What is Michelle Steffens's direct phone number?
Michelle Steffens's direct phone number is (847)-937*****
What schools did Michelle Steffens attend?
Michelle Steffens attended University Of Wisconsin-Parkside.
What skills is Michelle Steffens known for?
Michelle Steffens has skills like Validation, Quality System, Corrective And Preventive Action, Quality Assurance, Medical Devices, Gmp, U.s. Food And Drug Administration, Pharmaceutical Industry, Change Control, Verification And Validation.
Who are Michelle Steffens's colleagues?
Michelle Steffens's colleagues are Gideon Hecht, 小原吾郎, Jakub Cichocki, Walker Watson, Luis Guzmán Calvo, Elodie Chien-Wen Yang, Mba, Jamison Cocu.
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Michelle Steffens
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Michelle Steffens
Health Fitness Professional, Personal Trainer, Licensed Massage Therapist, & Certified Yoga InstructorWauconda, Il -
Michelle Steffens
Project Coordinator At S+B James Construction And Owner Of Learway Investments.Medford, Or2interiorofficeconcepts.com, interiorofficeconcepts.com
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