John Steichen Email and Phone Number
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Providing quality system, compliance and regulatory audits supporting ISO controlled, clinical trial, dietary supplement, in-vitro diagnostic, medical device, non-clinical and pharmaceutical industries.
Saint-Gobain Performance Plastics
View- Employees:
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Supplier Quality EngineerSaint-Gobain Performance Plastics Sep 2018 - PresentBeaverton, Michigan, United StatesResponsible for Supplier Quality Management Program: Performed external supplier audits (qualification and routine), deviation/customer complaint investigations (root cause analysis: fishbone diagram, 5 whys, risk assessment), negotiated supplier quality agreements, issued and managed Supplier Corrective Action Responses (SCARs), developed and issued Supplier Change Notifications to impacted customers.
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Gxp Quality AuditorIndependent Contractor Oct 2015Roscommon, MiPerforms Supplier Quality Audits according to ISO9001, ISO13485, 21CFR 210/211/820 (GxP) and ICH E6 Good Clinical Practices (GCP).
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Quality EngineerHyperion Materials & Technologies (Formerly Sandvik) Jan 2017 - Jul 2018West Branch, MiManaged: Metallurgy Laboratory, Liquid Penetrant and Final Inspection areas. Responsible for Calibration program, Document / Change Control system, Deviation - Customer Complaint / CAPA - Root Cause Analysis, Risk Assessment, Internal and External (vendor) audits.
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Mgr, Regulatory & Compliance ServicesSafis Solutions, Llc Apr 2007 - Oct 2015Medical Device/Pharmaceutical/Regulatory professional with extensive GMP/GLP/GCP/GxP/ISO, QA/QC and Regulatory Affairs background including:•Aseptic processing, cleaning, packaging, analytical method and computer validation•Raw material, finished product, medical device/pharma/food, approval/release, package component, and labeling: specification development•Third Party Organization (TPO), vendor audit and qualification•Stability program and product complaint management.•Risk assessment/management (FMEA, HACCP), Deviation Investigation, CAPA, trend analysis/metrics, Change Control, SOP development, annual product review, development/project management; Minitab, MasterControl, MS Office, Visio experienced.•Direct experience with FDA, EMA, MHRA, DEA.
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Qc ManagerEnzon Pharmaceuticals May 2006 - Mar 2007Indianapolis, Indiana AreaManaged chemists and technicians in the testing of raw materials, package components, finished product, stability analysis and analytical method validation.* company was sold to Sigma-Tau Group (reason for leaving) -
Product Release ManagerBristol-Myers Squibb Jun 2005 - May 2006Evansville, Indiana AreaManaged QA personnel supporting the release of solid dose, sterile parenteral and non-sterile drug products. Responsible for all on-site and Third Party Manufactured (TPM) products, resolving manufacturing process and laboratory discrepancies prior to finished product release.* BMS sold OTC product line (reason for leaving) -
Qa ManagerEndocyte May 2003 - Jun 2005West Lafayette, IndianaResponsible for implementing drug development quality systems, Third Party Manufacturer (TPM), GLP audits and CRO qualification, validation protocol development and approval, component qualification, scheduling of aseptic sterile fill operations, release of finished drug product testing, stability program management, and document change control. -
Team LeaderEli Lilly And Company Apr 1999 - Apr 2003Indianapolis, Indiana AreaManaged chemists and technicians supporting analysis of Insulin drug substance. Implemented equipment upgrades, revalidated test methods, and revised SOPs to bring laboratory to current GMP compliance. Managed quality and method validation for bio-analytical lab. Led process validation testing analysis for biotech products. Oversaw GxP quality program.
John Steichen Skills
John Steichen Education Details
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Chemistry / Biology
Frequently Asked Questions about John Steichen
What company does John Steichen work for?
John Steichen works for Saint-Gobain Performance Plastics
What is John Steichen's role at the current company?
John Steichen's current role is Supplier Quality Engineer.
What is John Steichen's email address?
John Steichen's email address is jo****@****ons.com
What schools did John Steichen attend?
John Steichen attended Concordia College.
What skills is John Steichen known for?
John Steichen has skills like Fda, Gmp, Pharmaceutics, Capa, Validation, Aseptic Processing, Change Control, Medical Devices, Computer System Validation, Drug Development, Regulatory Affairs, Regulatory Submissions.
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