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Q&A With Karen Kennedy

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Karen Kennedy
Project Leader, R&D, Covidien (Tyco Healthcare/Mallinckrodt)
Location: Prospect, KY United States
Joined: Jan 26th, 2001

About (request update)

My Interview Question

What is most important in your life?

Education (request update)

Hampton University class of 1992

Undergrad Major: Biology

Campus Organization:

Delta Sigma Theta

Fontbonne University class of

Grad Major:

High School: Los Alamitos High School in Los Alamitos, CA class of 1987

Experience

I currently work with Covidien (Tyco Healthcare/Mallinckrodt) as Project Leader, R&D
I have 15 years of experience working in the Manufacturing and Production industry.

Project Leader, R&D | Covidien (Tyco Healthcare/Mallinckrodt)
From June 2006 to Current • 20 year(s)
Management of new product development process activities including tracking resource expenditures, project status, coaching project leaders, and training technical personnel.

Manager, Regulatory Compliance | Tyco Healthcare/Mallinckrodt
From August 2004 to June 2006 • 2 year(s)
Oversaw regulatory compliance operations for St. Louis site quality unit of 30+ employees including change control, product release, stability program administration, and regulatory filings.

Supervisor, Plant QA | Tyco Healthcare/Mallinckrodt
From July 2002 to August 2004 • 2 year(s)
Supervised stability administration and label production/batch records accountability groups, implemented electronic inventory system for controlled substances, and ensured compliance with cGMP, FDA and ICH guidelines.

DEA Compliance Coordinator | Tyco Healthcare/Mallinckrodt
From August 2000 to July 2002 • 2 year(s)
Responsible for overseeing destruction of controlled substances, laboratory activities with respect to DEA compliance, and completing reports necessary for re-registration with the DEA.

Reference Standards Chemist | Mallinckrodt Inc.
From January 1997 to August 2000 • 3 year(s)
Group leader of an area that procured, subdivided, tested and certified high purity material for use of laboratory reference standards based upon FDA and USP guidelines.

Senior Quality Control Analyst | Mallinckrodt Inc.
From May 1995 to January 1997 • 2 year(s)
Responsible for wet chemical testing of raw materials and drug chemicals through the use of UV/VIS spectroscopy, autotitrators, Coulter counter and particle size analysis.

Quality Control Analyst | Mallinckrodt Inc.
From October 1992 to May 1995 • 3 year(s)
Responsible for wet chemical and instrumentation testing of in-process and finished product in the imaging department through the use of HPLC, GC, UV/VIS spectroscopy, and autotitrators.

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