1986 -
1989 Principal Engineer, Quality Management @
Mark Iwicki Education
Loyola University Chicago
BS (Biology)
1972
-
1979
Mark Iwicki Skills
ASQ
Validation
ISO 13485
CAPA
Quality System
FDA
Quality Auditing
Design Control
ISO 14971
Change Control
Calibration
Quality Management
GLP
Continuous Improvement
Six Sigma
GxP
V&V
Aseptic Processing
ISO
Quality Assurance
R&D
GMP
Supplier Quality
Computer System Validation
Product Development
Medical Devices
Manufacturing
Regulatory Affairs
Quality Control
Pharmaceutical Industry
Document Management
Sop
Software Documentation
Regulatory Submissions
Regulatory Requirements
21 CFR Part 11
Cleaning Validation
Technology Transfer
LIMS
Biopharmaceuticals
Biotechnology
Verification and Validation V&V
Corrective and Preventive Action Capa
u.s. Food and Drug Administration Fda
FDA GMP
ISO Standards
Computer System
Corrective and Preventive Action
u.s. Food and Drug Administration
Verification and Validation
Mark Iwicki Summary
Mark Iwicki, based in Wisconsin, United States, is currently a Senior Quality Professional at SQA Services, Inc.. Mark Iwicki brings experience from previous roles at NSF/Avarent, LLC, Regulatory Compliance Associates, Inc., Baxter Healthcare Corporation and Baxter Healthcare. Mark Iwicki holds a 1972 - 1979 BS in Biology @ Loyola University Chicago. With a robust skill set that includes ASQ, Validation, ISO 13485, CAPA, Quality System and more. Mark Iwicki has 2 emails and 1 mobile phone numbers on RocketReach.
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