John Steichen Email & Phone Number

Beaverton, Michigan, United States

Responsible 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.

Roscommon, Mi

Performs Supplier Quality Audits according to ISO9001, ISO13485, 21CFR 210/211/820 (GxP) and ICH E6 Good Clinical Practices (GCP).

West Branch, Mi

Managed: 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.

Medical 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.

Indianapolis, Indiana Area

Managed 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)

Evansville, Indiana Area

Managed 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)

West Lafayette, Indiana

Responsible 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.

Indianapolis, Indiana Area

Managed 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.