Qc Laboratory Business Analysis

Summary

Experienced IT professional primarily focused on GxP systems within the Bio-Pharma manufacturing space. Proven track record in IT Applications, QC Management and QC Laboratory roles developed through strong relationships with teammates and leadership. Respected for leveraging business analysis strategies to assess needs, communicate challenges, and facilitate cross-functional partnerships that drive business alignment.

Themes

Leadership: Early in my career I worked in the QC lab ascending into supervision/management roles that provided a strong foundation for GMPs, Quality and Compliance as it relates to the QC laboratory space.

Technical: I have been involved with many data systems which has provided a highly sought after skill set of being in the middle between IT and the laboratory/ manufacturing business processes. Starting with simple CDS systems for HPLC and GC, writing code in Fortran to operate NMRs, Operating and Maintaining SCADA systems to support QC Stability and becoming a LIMS SME, then LIMS Admin to LIMS Developer

Analytical: The past 13 years as a LIMS Developer has provided a detailed level of application configuration change management, debugging breaks, coding logic and support up to the level of understanding best industry practices into a GxP system. Both business and technical analysis are an everyday part of my professional experience.

Skills

GxP Systems: Extensive expertise with GxP systems such as LIMS, Empower, CDS, Veeva, Service Now, SAP, PLA, Isotrain and more within the Bio/pharma manufacturing space.

Languages: SQL, XML, CSV, ZPL, LW LIMS Basic

QC Management: Demonstrated ability to oversee QC processes, ensuring adherence to quality standards and driving continuous improvement initiatives.

QC Laboratory: In-depth knowledge of laboratory operations, instrument qualification, data integrity, and method validation within a regulated environment.

Business Analysis: Highly skilled in conducting thorough analysis to identify business needs, define user requirements, and propose effective solutions to optimize operations.

Cross-Functional Collaboration: Proven track record of building strong relationships and effectively collaborating with cross-functional teams to drive business objectives.

IT / Lims Experience

Consultant, LIMS Developer, Takeda Pharmaceuticals via USDM, Boston, MA June 2019—Current

LIMS master data updates and object life cycle.

Provide Tier 1, 2 and 3 application support.

Transform business requirements into design solutions.

Support continual improvement of the LabWare LIMS instance to promote operational excellence and SDLC.

Consultant, LIMS Developer, RJ Reynolds via TEKSystems, Winston-Salem, NC Jan 2019—June 2019

Designed and Developed Investigation Templates per business requirements.

Created Subroutines in support of data parsing via CSV and XLS format data files.

Consultant, LIMS Developer, Noven Pharmaceuticals via Genius Software, Miami, FL July 2017—Dec 2018

Part of a three-member team responsible for design and development for a fresh install of LabWare v7 LIMS.

Notable achievements and accountabilities not previously mentioned include Master Data: Analysis, Products, Batch Objects, Test Lists, Subroutines, Format Calcs, Query Tags, Access Routines, Standards and Reagents, Menu Routines, User Dialogs, Roles, and Role Security.

Promote organizational business process harmonization and alignment by proactively engaging stakeholders across multiple business areas to understand and mitigate barriers to successful technology adoption.

Interfacing: JD Edwards, Empower3, and TrackWise.

Coding: SQL and LabWare LIMS Basic.

Software Group Leader / Senior IT Consultant, Sequence Inc, Morrisville, NC July 2014—June 2017

IT Applications, Consultant, Pfizer via Sequence Inc, Rocky Mount, NC Nov 2016—July 2017

Thermo Fisher Sample Manager LIMS: Master data builder for Analyses, Product Specs, Item Codes, Sample Plans, QC Samples, Environmental Monitoring, and Format Calculations, IT Change Control Procedures, Tier 2 service request issues related to LIMS.

IT Applications, Consultant, BD via Sequence Inc, Morrisville, NC July2015—Nov 2016

LabWare LIMS version 7: ELN design and development, subroutine coding between ELN and base LIMS. Member of a design and development team for UI’s and VWFs in support of LIMS prototype. Static master data builds for analysis, product specs, and ELN templates. Subroutines, ELN, SQL queries, User Dialog Menus, Menu Routines, Sample Login Templates, Format Calculations, Access Routines, and Test Lists.

IT Applications, Consultant, Biogen via Sequence Inc, Morrisville, NC June 2014—Nov 2016

LabWare LIMS versions 7,6,5 and Empower Administration: Master Data builder for LabWare LIMS Analyses, Batch Templates, Product Specs, Item Codes, Sample Plans, QC Samples, Test Lists, and Format Calculations following company IT Change Control Procedures. Handled Tier 2 service request issues related to LabWare LIMS.

Consultant, IT, Biogen, BiogenIDEC via Randstad/Sapphire, Morrisville, NC July 2011—June 2014

LabWare version 6,5, primarily configuration for static data builds such as analysis, product specs, batch test templates, QC Samples, Test Lists, and Format Calculations.

QC Laboratory Experience

Senior Research Associate, Élan Drug Technologies Inc., King of Prussia, Pa Feb 2007—June 2011

Part of GAMP-5 validation project team to implement LabWare LIMS system into QC environment. SME deliverables included but not limited to where to develop, test, and validate LIMS analyses. Create and modify LIMS Master Data change requests. Develop SQL queries where data was used to support metrics for business analysis.

Senior Chemist, Discovery Labs, Warrington, Pa July 2006—Feb 2007

Managed sampling and disposition of incoming materials (raw materials, bulk tablets, packaging components, etc.) in addition to non-conforming Materials quality as primary interface with vendors as well as import liaison for US Customs, USDA, and FDA requests for information for incoming commodities. Enterprise IT system implementation of SLIM-STAT.

QC Biochemistry Supervisor, IDEC and Biogen-Idec, Torrey Pines and Oceanside, CA Mar 2003—Jan 2005

Managed the validation of various instrumentation and equipment and participated and/or led audits of various departments including QC Biochemistry stability. Gained expertise as point person for all QC-related HPLC and IEC issues, as well as, responsible for lab cell culture.

Senior Chemist, Alliance Pharmaceutical, San Diego, CA Jan 2002—Sep 2002

Served as QC stability lead for clinical manufacture, as well as LIMS evaluation and selection team lead. I joined the company in late phase 2 clinical trials for the product Oxygent which failed to get approval after phase 3 trials.

QC Supervisor, In-process Testing, Aerojet Fine Chemicals, Sacramento, CA July 1999—Oct 2001

Supervised a team of 12 chemists providing 24-7 support for QC in-process testing of API material for a contact manufacture. Deliverables include sample and test planning for resource allotment, analytical method development and transfer of both in-house and/or customer provided, regulatory and customer audits and the responses, daily engineering meetings to discuss in-process results, issues, and/or investigations which required QC support.

QC Chemist II, Johnson Matthey Pharmaceuticals, West Deptford, NJ Nov 1997—July 1997

Performed chemical analysis, primarily HPLC and GC of raw material, in-process, and finished products in a QC environment; assisted in method transfer from Analytical Method Development group.

Associate Scientist, Biopharm Pharmaceuticals, Fort Washington, Pa Nov 1995—Ju1y 1997

Part of analytical method development team, primarily focused on GC and HPLC, as well as, performed compendia testing for a small clinical scale manufacturer.

Education

BA, Chemistry, 1995

Virginia Polytechnic Institute and State University (Virginia Tech)

Blacksburg, VA

References

Available upon request

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