Manager Project

SUMMARY:

Experience includes: Equipment validation, LIMS implementations, laboratory

instrument qualification, software validation, training, and support of FDA

regulated GMP Manufacturing Quality Control and Pharmaceutical Development

Laboratories. In addition, I possess excellent communication and

presentation skills.

Industry Experience: Pharmaceutical, Life Science

LIMS Functionality: LIMS was fully integrated into Pharmaceutical

Manufacturing (In-process testing), Environmental Monitoring, Analytical

and Micro Laboratories, Cleaning Verification, Validation and Quality

Assurance. All Product Specifications, Analysis, Instrumentation,

Standards&Reagents, Reports and Laboratory Investigations were configured

in LIMS.

Scientific Application (or Instrumentation): LabWare LIMS, STARLIMS,

SampleManager LIMS, HPLC/GC Instrumentation on a Server-Client Network,

FTIR Spectrometer/OMNIC, ANC Titrator/Workcell, ICP Spectrometer/TEVA,

Atomic Absorption Spectrometer/Winlab, UV/VIS Spectrometer, Particle Sizer

Analyzer/LA-300, Vitek Instrumentation/Bio Liaison, NuGenesis

Degrees/Certifications:

M.S. Quality Assurance/Regulatory Affairs, Temple University School of

Pharmacy

B.S. Chemistry, Alvernia College

PROFESSIONAL EXPERIENCE:

Herbalife International of America,

Inc January 2014 to September 2014

3200 Temple School Road

Winston Salem, NC 27107

Validation Engineer

Worked as a contractor, part of validation team, responsible for equipment

validation activities at Herbalife Innovation and Manufacturing site,

during facility start-up. Execution of validation activities were done

according to GMP, Herbalife, SOP and any other applicable regulatory

requirements. Developed, authored, and executed validation protocols.

Assisted validation manager in qualification and validation projects, as

needed.

P1 Production equipment validation includes:

. Installation and Operation Qualification of the Sacmi Automatic Rotary

Labeling Machine with Vision Inspection System

. Installation and Operation Qualification of the Domino A-Series

Printer

. Installation and Operation Qualification of the US Bottlers Capper

. Installation and Operation Qualification of the Bottle Coder

. Installation and Operation Qualification of the Case Printer

Laboratory instrument validation included:

. Tuttnauer Steam Sterilizer IOPQ

Eurofins/Lancaster Laboratories

August 2012 to May 2013

950 Reynolds Boulevard

Winston Salem, NC 27105

LIMS Systems Analyst

As a LIMS team member, delivered approved projects and ensured that all

activities adhered to relevant policies, SOPs and regulations in a non-GMP

environment.

. Provided support to end users of Labware LIMS v5 at RJRT company R&D

laboratories; responsible for system administration, user technical

support and training related to use of Lab Ware LIMS.

. Gathered requirements from laboratory to develop new GCMS, LC and Raw

Material methods. Collaborated with analysts for data to test

calculations, executed results in excel. Upon stakeholder approval

promoted analysis to production.

. Maintained current LWLIMS; developed and implemented new configuration

of the system, ensured that proper change control procedures were

followed.

. Provided technical support on the troubleshooting, diagnosis and

resolution of LIMS issues, in addition to fixing bugs.

Alpha Consulting Corp.

October 2011 to June 2012

9 Auer Court Suite E

East Brunswick, NJ

Scientific Specialist W/Labware LIMS

. Participated on a BMS project team to implement Labware LIMS v6 to

support research Process Development and Biologics manufacturing.

. Interacted with LIMS end users and business leads to translate

requirements into maintainable configurations, used test cases derived

from the user requirements.

. Worked with BMS consultant to validate software.

. Collaborated with Project Manager to validate and implement Labware

LIMS.

. Developed Remedy application with roles to document and resolve user

issues.

. Created virtual workflows for each role with appropriate user

functionality.

. Used Dashboard to track sample volume and status with Labware LIMS

application.

Sun Pharmaceutical Industries Inc

March 2011 to October 2011

270 Prospect Plains Road, Cranbury, NJ

LIMS Specialist

Lead implementation of in-house developed LIMS

. Created workflows using MS Visio, in addition to specifications for

raw materials and product.

. Collaborated with business owners, scientists and developers to

improve the LIMS process.

. Responsibilities included the build, administration, support and

training for implementation of a SUN LIMS to US sites

Technisource

March 2010 to December 2010

New Brunswick, NJ

LIMS contractor, Application Support

Provided support for Thermo SampleManager LIMS implementations at BMS.

. Executed validation test scripts in DEV and TEST environments before

promotion to production under change control.

. Validated Infomaker report functionality.

. Provided support for LIMS users, resolved helpdesk tickets for LIMS

issues from global sites

. Utilized Sample Manager's enhancements in EM Module; used scheduler

tool for the lab systems.

ImClone Systems Incorporated, Branchburg, NJ 2008 to

2010

LIMS Administrator II

. Assisted in the STARLIMS implementation and maintenance of

computerized systems within the QC laboratories. Provide support to

the QC laboratories in the area of computerized laboratory systems and

databases.

. Ensure that QC computerized systems are validated and maintained in a

manner compliant with corporate and regulatory requirements including

21 CFR Part 11 and GAMP 5.

. Provide user training, and interface with system owners, IT, QA and

vendors related to the QC systems.

. Subject matter expert for the business and STARLIMS.

Centocor, Spring House PA 2005 to

2007

Project Lead, LIMS Administrator

. Responsibilities include design, develop, execute and implement

LabWare LIMS into the Pharmaceutical Development Quality Control

Laboratories and manufacturing processes. The LIMS workflow replaced

the current paper-based process, which provided test results to Pilot

Plant operations, maintenance of laboratory records and data storage.

The LIMS applied scientific principles, technical expertise and

product knowledge to current laboratory processes.

. Configured Labware LIMS workflows from batch records for support of in-

process and finished product testing compared to specifications.

. Supported Cleaning Verification equipment and EM/Water testing using a

LabWare Environmental Monitoring module to automate scheduling of all

equipment/sampling points, label printing and associated testing from

SOP procedures.

. All laboratory equipment, instrument calibration/maintenance and

reagent preparations were tracked in LIMS.

. Development Quality Control Laboratory.

. Certified LabWare LIMS System Administrator.

Johnson & Johnson/Merck 1999 to

2005

Quality Systems Senior Chemist

System Administrator of laboratory data systems and technical services role

in laboratory support.

Part 11/Technical Services:

. Initiate and secure change controls for all new laboratory equipment

purchases

. Evaluate Laboratory Instruments Purchase Options, Vendor contact, Secure

quotes, Purchase equipment

. Prepare all validation documentation including IOPQ protocols and

reports, route documents through approval process

. Facilitate Laboratory Equipment Installation

. Assist vendor I/OQ, execute entire IOPQ protocols, supplemental I/OQ and

perform in-house PQ

. Satisfy all change control requirements and change control closure

. Maintain OOS Database and prepare Annual OOS Investigation Report

. Review and sign-off laboratory calibration data

. Schedule and Facilitate calibration performed by vendors and alert

laboratory of calibration due each month

. Obtain quotes and purchase of Service contracts for Software and

Instrumentation

. Point contact for Millennium Total Assurance Plan

. Prepare Appropriation Requests for Laboratory Equipment

. Review of Laboratory Equipment Logbooks

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