EXECUTIVE SUMMARY:

• Experienced IT Systems Specialist with ten years of experience providing end - user support services and business-wide solutions.
• Responsible for the installation, calibration, project planning, and training for multiple laboratory software platforms and instruments.
• Well versed with LMS interface configuration, as well as multiple CDS systems.
• Led the evaluation of LabVantage 8 SaaS utilizing Amazon Web Service (AWS).
• Led a pilot program to evaluate the usage of IDBS SaaS in chemical and biological laboratories.
• Presented on the benefits of the IDBS E-WorkBook Cloud to upper management.
• Assisted in the revalidation of an enterprise LIMS system while also managing a major system-wide upgrade.
• Completed a CFR21 Part 11 assessment and drafted SOP’s to address gaps.
• Acted as the lead trainer on a trip to Puerto Rico during new system rollout.
• Administered systems across multiple geographies while also proposing a harmonization process for the more complicated systems.
• Provided audit response and assistance during a pre-launch audit by the Confidential .
• Successfully developed educational programming involving information systems utilized in high-volume analytical laboratories in addition to supporting R&D and Quality Control of commercial product manufacturing.
• Created training check programming for Cornerstone LMS and managed employee activity in Workday.
• Seasoned and reliable resource for Confidential and DEA audits as well as 21 CFR Validation.
• Consistently demonstrated history of work excellence in Commercial Production at Confidential and Confidential while supporting the manufacture and lot release activities related to marketed product.
• Efficiently operated in a regulated clinical environment that produced products subject to both domestic and foreign regulatory bodies. Maintained technical systems deployed on the medical device manufacturing lines. Worked with Regulatory and Quality departments to efficiently utilize the corporate CRM SaaS application that was available at the time.

EXPERTISE:

Cornerstone LMS Waters Empower 3 Software Amazon Web Service (AWS)

Data Analytics Chromeleon CDS Spotfire Data Analytics and Visualization

SAP SaaS LC-MS, NMR, IR, UV-VIS CFR21 Part 11 Software Validation

Veeva Vault LMS LabWare LIMS versions 5-7 SAP S/4HANA Business Suite

Technical Writing Waters NuGenesis LMS systems cGMP/GLP compliance

IQ/OQ/PQ evaluation Software and Report Validation SQL

SDMS/LES implementation Cloud Computing CAPA Management

PROFESSIONAL EXPERIENCE:

Independent Consultant

Confidential, Minneapolis, MN and Boston, MA

Responsibilities:

• Generated detailed presentations using Spotfire analytics for stakeholders
• Consulted on the steps required to address the European Union’s new Medical Device Regulation (MDR)
• Continued work to obtain Project Management and Six Sigma Certification
• Pursued coursework in the fields of Data Security and Data Science
• Worked with partners to continue the development of a prototype resource management program system based on relational databases.
• Developed training material for use in new system deployment as well as refresher training on existing infrastructure

Confidential, Minneapolis MN

Senior IT Business Analyst

Responsibilities:

• Tested, analyzed, and reviewed numerous LIMS/SDMS/LES systems including LabWare LIMS, LabVantage 8.0, Thermo Scientific, and StarLIMS.
• Partnered directly with end users providing and managing the support for data acquisitions and management systems including but not limited to LabWare LIMS, SDMS Waters NuGenesis & Empower with a high attention to detail.
• Observed business workflows and needs in order to generate requirement documentation and system design plans
• Trained end users on system use and Part 11 responsibilities within all Lab Applications and wrote related SOP’s
• Utilized Spotfire to generate visual displays for upper management to describe the financial situation within the business unit
• Brought 1 Million dollars’ worth of equipment online in a 3-month period with full validation and qualification required
• Consulted on the selection of hardware and software vendors in an effort to create uniform quality standards
• Led the deployment and hyper-care team in the implementation of LIMS and ELN solutions at satellite facilities in Puerto Rico while working on Confidential submission documentation to finalize the move.
• Utilized lean business principles and quality improvements to reduce business cost and reduce or eliminate suboptimal laboratory processes
• Executed and delivered application training & support to users of laboratory information systems including but not limited to LabWare LIMS, NuGenesis LMS ELN, NuGenesis LMS SDMS, and Empower.
• Contributed to the creation of a fully CFR21 Part 11 compliant validation system for use with software, reports, and lab systems.
• Executed this network of procedures in the validation of multiple software packages, instrument systems, and reports.
• Validated data integrity during the reporting process, as well as during the initial transfer of data from the instrument or interface into the data storage system.
• Provided audit response and assistance during a recent pre-launch audit by the Confidential .
• Led the deployment team that introduced an entirely electronic network of ELN and LIMS technology to Puerto Rico. This was in response to an Confidential demand that was ordered before my arrival at the company, but I led a key section of the team that closed this project out.
• Contributed to the revalidation of LabWare LIMS and all built-in functionality.
• Validated three separate dynamic reports that were submitted for regulatory review and eventually released for production use.
• Created custom reports on a user-requested basis and determined specific levels of validation based on the intended use.

Confidential, St. Cloud, MN

Project Consultant

Responsibilities:

• Provided IT support to end users implementing technical solutions for process improvements and increased productivity.
• Participated in Confidential and DEA audits of both laboratory documentation, API storage, and electronic systems
• Evaluated and improved daily lab operations, while documenting recommendations for appropriate staffing of lab and pricing of assays.
• Defined and maintained a database of specimens while developing compliant procedures to ensure data integrity
• Enhanced product formulation development and restricted molecular biology analysis
• Conducted and verified quality control tests and directed test procedures
• Determined equipment-operating efficiency and led the research team on simultaneous projects.
• Increased process efficiency and research capabilities by influencing productivity and increased workflow.
• Developed and refined product formulation SOP's and methods to improve product performance.

Confidential, St. Paul, MN

Analytical Chemist

Responsibilities:

• Orchestrated the deployment of IT solutions to support laboratory instruments and technical staff.
• Participated in multiple Confidential and DEA audits of laboratory records, API use documentation as well as electronic audits of ELN and Empower systems.
• Participated in documentation procedures for Confidential submissions.
• Assisted with the validation and eventual release of a global ELN solution
• Developed, validated, and transferred analytical methods and SOP's for a wide variety of test methods that used HPLC, GC/MS, FTIR, and extraction instrumentation to identify purity and potency of chemical compounds and experimental drug formulations.
• Collaborated with labs during any instrument or experimental troubleshooting that arose for lab procedures and unexpected events in lab operations.
• Evaluated SOPs and methods to improve product performance for new market opportunities.
• Maintained laboratory instruments and performed IQ/OQ/PQ on new equipment.
• Deployed analytic techniques to data collected based on personal knowledge, technical experience, and other conditions affecting unexpected results.
• Utilized data presentation tools such as Spotfire to help assuage customer complaints
• Orchestrated and troubleshot laboratory instruments. Established and maintained records for all regulatory audits.

Confidential, Duluth, MN

Undergraduate Lab Supervisor

Responsibilities:

• Supervised laboratory personnel, provided IT technical solutions, conducted and oversaw Quality Assurance and Quality Control
• Trained students on proper documentation practices and enhanced maintenance and instituted Quality Control logs to develop good laboratory practices
• Supervised and centralized the University Lab safety policies and procedures by building a culture based on safety
• United management in developing and implementing technology policies and procedures.
• Provided support for University and NIH audits of laboratory procedures and documentation