Lab Systems Software Development

SUMMARY

Extensive experience in Computer System Validation, SDLC processes, Data Integrity and Compliance Auditing, Testing, trouble shooting, training and administration.

LIMS/LIS Expert with proven success in Planning, Requirements gathering, Configuring, Implementing and Validating LIMS and LIS.

Chromatographic Data System Implementation and Administration by maximizing problem solving, interpersonal, and electronic information management skills in a regulated environment.

Highly efficient at researching and data extraction with strong ability to study, analyze and detect errors. A proven leader and an excellent communicator recognized for ability to establish and maintain effective working relationships across cross-functional teams and diverse individuals at any levels.

TECHNICAL SKILLS

Proven knowledge of Computer-related System Validation in FDA regulated industries with Laboratory Systems and Manufacturing systems, Knowledge of Database Architecture, Validation of Electronic Records and Signatures, Managing 21 CFR Part 11 Assessment Program/Gap Analysis, 21 CFR 200 series and cGMP/GLP

Develop Computer Validation documents such as user requirements, functional requirements, user acceptance tests, performance qualification test scripts, validation summary reports.

Computer skills: Sapio Sciences Exemplar LIMS Administration, Core LIMS Administration, LabCollector LIMS, Nautilus LIMS Administration, LabWare LIMS Administration, SQL*LIMS Administration, LabWorks Administration, Windows Administration, ERP systems, Medgis LIS, L+R+ (inhouse developed LIS)

Extensive experience in Data Integrity and Compliance with multiple Chromatographic Data Systems, Laboratory Information Management Systems, and other Computer- related Laboratory/Manufacturing Systems with strong facilitation skills.

Hands-on experience with vendor audits to evaluate the SDLC, change control process, developing user-training materials, SOPs and user guidelines and validation test scripts.

PROFESSIONAL EXPERIENCE

SEMA4, NEW YORK, NY 07/2019 – 11/2024

Laboratory Information Manager

Responsible for the successful implementation of Laboratory Information Management System

AKORN PHARMACEUTICALS, AMITYVILLE, NY 05/2017 – 07/2019

QC Data Integrity and Compliance Supervisor – Major Responsibilities

Providing data definitions, establishing quality expectations and ensuring compliance to those expectations

MICROBAC LABORATORIES, WILSON, NC 07/2013 – 04/2017

LIMS Administrator/IT Manager – Major Responsibilities

Leadership in LIMS selection, implementation and validation processes across the sites.

REGENERON PHARMACEUTICALS, INC. TARRYTOWN, NY 05/2008 – 06/2013

LIMS Analyst – Major Responsibilities:

Responsible for LIMS documentation, including, converting User Requirement Specification to a Detail Design Specification, writing configuration Test Plans etc.

WATSON LABORATORIES, INC. CARMEL, NY 1995 – 2008

Laboratory Systems Administrator – Major Responsibilities:

Computer-Related Systems Validation Responsibilities:

Responsible for developing and administering policies and requirements for the validation of computer-related systems

Developing Plan Chronology, Validation Plan, Change Control and Configuration Management, Developing system requirements, functional design and system specification, installation and operational qualification protocols, standard operating procedures, performance qualification protocols and validation summary report.

Laboratory Information Management System (LIMS) Responsibilities:

Responsible for implementing, maintaining and supporting LIMS

UNION CARBIDE CORP. TARRYTOWN, NY 1987 – 1993

Analytical Chemist – Major Responsibilities:

Analyzing samples using technologies like induction coupled plasma (ICP) emission

spectrometry, atomic absorption, normal and reverse phase high performance liquid chromatography, gas chromatography and classic wet chemistry.

EDUCATION

Master of Science, Analytical Chemistry

TRAINING / CERTIFICATIONS

Sapio LIMS Administration

Core LIMS Administration

Medgis LIS Administration

L+R+ LIS

Nautilus LIMS Administration

LabWare LIMS Certified Administrator

SQL*LIMS Administration

Empower Software Enterprise System Administration

Empower Software Advanced Topics with Lab

Managing Data Integrity and Compliance in Regulated Industries

HP ChemStation / ChemStore

Microsoft Office Word, Excel, Visio, MS Project, PowerPoint

Computer-related System Validation in FDA regulated industries

Computer and Software Validation/Electronic Records and Signatures

21 CFR Part 58, 210 & 211, and Part 820

Managing 21 CFR Part 11 Assessment Program/Gap Analysis

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