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Project Manager Quality Control

Location:
3079
Posted:
April 08, 2010

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Resume:

Charles R. Landry

*** **** ** **** #*

Salem, NH 03079

603-***-****

*******.******@*****.***

PROFESSIONAL EXPERIENCE:

Boston Analytical Salem, NH

CDS Senior Administrator October 2007-Present

• LIMS implantation SME

• Project Managed the Atlas Chromatography Data system validation upgrade

• Manage the current Chromatography Data system, which includes the following responsibilities:

The CDS Terminal and Application Servers operation.

The Chromatography Instruments using the Instrument Manager application.

The Client Server Configurations.

Maintain the DataServers/Instrument Controllers.

Responsible for end user and system settings.

Perform periodic audits of the system.

Maintain the CDS Standard Operating Procedures.

• Other non-CDS responsibilities include, Project Manage system and instrument validations.

Technical Manager April 2006-October 2007

• Managed the Technical Group. The Technical Group is responsible for performing equipment maintenance, from calibration

and technical support to Quality Control, in Chemistry and Microbiology Laboratories.

• Project Manager for all new instrumentation validations and stability chamber qualifications, which included temperature and

humidity mappings.

• Responsible for overseeing Boston Analytical's capital budget.

Bristol-Myers Squibb Medical Imaging Billerica, MA

April 1988-April 2006

Radio Analytical Services Group

Quality Scientist September 2003-April

2006

• BMSMI representative for the NIST Radio Pharmaceutical steering committee.

• Program Manager the BMSMI Nuclear Energy Institute-NIST Traceable and Isotope Secondary Standards Program, which

included:

The NIST program, BMSMI In-house program, Quality and Manufacturing’s Capintec Calibration and Linearity programs

and Annual Efficiency Verification programs for HPGe detectors, NaI detectors and Liquid Scintillation Counters.

• Accountable for the Quality Control Radiation Detector System, ICP Lab and Alpha Analyst Spectroscopy System.

• Project Manager for instrument and/or methods validations.

• Performed daily Calibration & ICP Lab testing, which included Liquid Scintillation Testing, Gamma Spectroscopy, Gamma

Counting, Inductively Coupled Plasma Spectroscopy, and Keithley 4pi Assay.

• Project Team Member (SME) for the Continuous Innovation Metrology Team: focused on optimizing the Metrology

Calibration Process.

• Performed QA final product release review on as needed basis.

Quality Control Radiometrics

Associate Scientist August 1999-September 2003

• Performed Calibration Lab Testing, including Liquid Scintillation Counting, Gamma Spectroscopy, Gamma Counting,

Inductively Coupled Plasma Spectroscopy, and Keithley 4Pi Assay.

• Classified as a Radiometrics "Super User" (SME) for Inductively Coupled Plasma Spectroscopy and the Chromatography

Data System (CDS).

• Responsible for training new users, maintenance and calibration of equipment.

• Maintenance of related SOP’s.

• Member of Chromatography Data Acquisition Validation Team.

• Performed all Sr. Technologist testing and project management.

Quality Control Radiometrics

Sr. Technologist August 1994-August 1999

• Independently managed various key projects for Radiometrics, in addition to performing all final product testing

• Classified as a Radiometrics "Super User" (SME) for HPLC, Graphite Furnace Spectroscopy.

Major Projects included:

Project Manager for instrument validations.

Program Manager for the Maintenance and Calibration Program for the Radiometrics’ laboratory analytical instrumentation.

Performed Final Protocol Testing of Quadramet prior to Commercialization.

Maintained Consumables Inventory.

Performed Endotoxin Testing by KQCL.

Selectively chosen for key projects supporting the Analytical Services Group including Yttrium 90 Project and Interlab

Qualification of Cardiolite™.

Executed Final product testing of Nuerolite™/Cardiolite™ including radiolabeling & RCP determination by HPLC and TLC.

Quality Control Radiometrics

Technologist April 1992-August 1994

• Performed Final Product Testing on Thallous Chloride, Gallium Citrate, Technetium Generators, and Xenon Gas, which

included:

Radio Chemical Purity Test by Thin Layer Chromatography, Metal Concentration Test by Wet Chemistry Radionuclidic

Identification & Purity by Genie Spectroscopy.

Radionuclidic Concentration Determination

Benzyl Alcohol Determination by UV Spectroscopy

Endotoxin Testing by Gel Clot

Molybdenum Breakthrough Analysis by Sodium Iodide Detection

Technologist – Manufacturing February 1991-April 1992

Prepared batch formulations of Thallous Chloride and Gallium Citrate per SOP‘s and cGMP.

Associate Technologist – Manufacturing March 1988-January 1991

Prepared packaging for and visually inspected Thallous Chloride and Gallium Citrate for final product release.

EDUCATION:

Middlesex Community College, Lowell, MA

Associate of Arts - Liberal Arts and Science, May 2001

Additional Courses

• LIMS and Laboratory Systems Integration: How to Select, Plan and Implement the Right Software Solutions for Your

Laboratory 03/10

• Thermo Fisher CDS Atlas Advanced System Administration/Instrument Control/Report Managing, 04/08

• Coaching, Mentoring & Team-Building Skill, 08/06

• Thermo Fisher CDS System Administration for Atlas, 06/06

• General Theory of Gamma Spectroscopy, 09/05

• Continuous Innovation Team and Tools, 09/05

• Coaching and Teambuilding Skills for Managers and Supervisors, 08/05

• Project Management, 08/04

• Apex Gamma Spectroscopy Software Operations, 06/04

• Techniques of Simultaneous ICP-OES, 12/03

• 21 CFR part 11 Compliance Seminar 6/03

• Train the Trainer, 06/01

• Agilent HPLC including Troubleshooting & Maintenance, 09/99

• Graphite Furnace Atomic Absorption, 08/99

• The Use of MulitChrom Data Acquisition System CDS, 06/97



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