Mitchell Kimberly M Januszewski

Principal And Board Member

view source

Location:

10411 Corporate Dr, Pleasant Prairie, WI 53158

Industry:

Pharmaceuticals

Work:

Regulatory Compliance Associates, Inc. since Jun 2013
Principal and Board Member
Regulatory Compliance Associates Inc. Jan 2001 - Jun 2013
President and CEO
Oak Grove Technologies Inc./ Quintiles 1994 - 2000
President
Baxter Healthcare 1980 - 1993
Engineering Mgr

Education:

University of Illinois at Urbana-Champaign 1973 - 1977
University of Wisconsin
BSME, Mechanical Engineering

Skills:

Medical Devices
Fda
Capa
Iso 13485
Gmp
Validation
V&V
Pharmaceutical Industry
Design Control
Quality System
21 Cfr Part 11
Change Control
Regulatory Affairs
Cross Functional Team Leadership
Biotechnology
Quality Assurance
Sop
21 Cfr
Root Cause Analysis
R&D
Regulatory Requirements
Six Sigma
Quality Auditing
Technology Transfer
Design of Experiments
Medical Equipment
Biopharmaceuticals
Quality Control
Iso
Contract Manufacturing
Aseptic Processing
Regulatory Submissions
Computer System Validation
Gxp
Quality Management
Dmaic
Supplier Quality
Pharmaceutics
Clinical Trials
Commercialization
Fmea
Glp
Manufacturing Operations
Biomedical Engineering
Clinical Development
Iso 14971
Fda Gmp
Cleaning Validation
Program Management
Lifesciences

Mitchell Januszewski

view source

Mitchell Januszewski