Mark Triplett Email & Phone Number

Austin, Tx, Us

San Clemente, Ca, Us

• Created SharePoint sites for inter-lab communication, safety, and project tracking.• Lead project for selection and implementation of Chemical Inventory software for the QC labs.• Developed Lab Systems Windows patching policy to prevent interruptions to critical experiments and runs for QC labs.• Worked with corporate and local network teams to create and populate all validated lab systems into a protected Active Directory group to prevent automatic installation of Windows updates.• Worked with Lab validation group to develop an on-site vendor list of services that were approved to be performed without change control on validated lab systems by approved vendors.• Coordinate with Validation and Compliance groups to ensure secure setup of new and existing lab systems.• Provide strategic direction to the IT, Laboratory, and Management teams based on a combination of industry and technical knowledge.• Lead data migration requirements for LIMS stability data transfer.• Lead data integrity and CFR 21 Part 11 compliance by outlining, articulating and configuring system requirements.• Gather and document business objectives, specifications and requirements on medium/large size projects.• Act as an IT lab administrator of applications (Labware LIMS v7, Empower 3 FR5, Thermo Chromeleon v7.2.10, various Perkin Elmer software systems, and TOC) supported within the organization. • Mentor/train junior team members on specific business areas and systems.• Act as primary IT department reviewer and signatory for all laboratory computer-based system validations

Austin, Texas, Us

• Developed Lab Systems Windows patching policy to prevent interruptions to critical experiments and runs for R&D, QC, and GMP. • Implemented Autoscribe Matrix Gemini LIMS for QC EM. • Managed the Temperature monitoring system (iSensix) for all R&D, QC, and GMP temperature sensitive storage equipment. • Administrator for Thermo Chromeleon 7.3 HPLC (Vanquish) and Cytiva Unicorn 7.6 LC (AKTA) systems.• Administrator for lab systems such as CLC Genomics, Agilent 2100 Bioanalyzers, Biotek Plate Readers, Charles River Endosafe, Eppendorf DasGips and Bioflos, Shimadzu and Sievers TOCs, • Act as primary IT department reviewer and signatory for all laboratory computer-based system validations. • Lead data integrity and CFR 21 Part 11 and GAMP compliance by outlining, articulating and configuring system requirements.

Rahway, New Jersey, Us

• Lead both the LabWare LIMS Desktop Support (5 people) and Bugfix (5 people) teams addressing concerns raised in production incidents/CAPA commitments for 22 sites.• Increased bugfix team patch release rate from every 6 months to every 3 months.• Lead 18 change controls after upgrading from LabWare LIMS v6 to v8 in 3 months.• Organized and coordinated system releases to limit business impacts due to downtime while enabling changes to support business initiatives.• Utilized JIRA, Confluence, and Bitbucket, and HP ALM for development, testing, and installation of LIMS bug patching.• Developed relationships with business sites to become the lead point of contact for early reporting of issues and subsequent resolutions by the bugfix teams. • Mentored and trained junior team members to handle site related issues for our global team.

San Clemente, Ca, Us

• Created checklist for all current and new validated lab systems to have USB locking put in place to adhere to Data Integrity standards.• Worked with corporate and local network teams to create and populate all validated lab systems into a protected Active Directory group to prevent automatic installation of Windows updates.• Worked with Lab validation group to develop an on-site vendor list of services that were approved to be performed without change control on validated lab systems by approved vendors.• Coordinate with Validation and Compliance groups to ensure secure setup of new and existing lab systems.• Provide strategic direction to the IT, Laboratory, and Management teams based on a combination of industry and technical knowledge.• Lead data migration requirements for LIMS stability data transfer.• Lead data integrity and CFR 21 Part 11 compliance by outlining, articulating and configuring system requirements.• Gather and document business objectives, specifications and requirements on medium/large size projects.• Act as an IT lab administrator of applications (Labware LIMS v7, Empower 3 FR1, various Perkin Elmer software systems, and TOC) supported within the organization. Mentor/train junior team members on specific business areas and systems.• Act as primary IT department reviewer and signatory for all laboratory computer-based system validations.

Sugar Land, Tx, Us

• Work with business to identify data needs for new LIMS and/or an Electronic Lab Notebook system • Provide strategic direction to the IT, Scientific, and Management teams based on combination of industry and technical knowledge• Create and maintain SDLC documentation.• Work with Development team to implement and test accuracy and completeness of data migration • Contribute in all areas of system implementation including but not limited to vendor interaction, system compatibility, change control, qualification, deployment, and training• Work with project teams to ensure compliance with regulatory requirements such as FDA, CAP, CLIA, as well as internal policies and processes• Identify the optimum combination of applications that meet the requirements of disparate laboratory and business functions

Illinois, Us

• Lead the data management team and process, outlining and articulating business rules required for data accuracy and consistency as well as resolving any data quality issues • Gather and document business objectives, specifications and requirements on medium/large size projects.• Develop, and execute unit/system test cases, scripts and plans. Facilitate testing activities within the team.• Define, design and document business flows and processes for medium/large projects.• Act as administrator of applications (SQL*LIMS, NWA, LIMSLink, Business Objects) supported within the organization. Mentor/train junior team members on specific business areas and systems.• Identify, analyze, propose and document appropriate solutions for problems and issues that may impact the project, acknowledging the broader business impact. Use technical tools (queries, process maps, etc.) for problem resolution.• Disseminate status, concerns, and solutions in a timely manner within the team and across functions, establish and maintaining relationships within the business or function.• Provide cross-functional and business knowledge to develop business system and process alternatives.

Deerfield, Illinois, Us

• Lead the data management team and process, outlining and articulating business rules required for data accuracy and consistency as well as resolving any data quality issues • Gather and document business objectives, specifications and requirements on medium/large size projects.• Develop, and execute unit/system test cases, scripts and plans. Facilitate testing activities within the team.• Define, design and document business flows and processes for medium/large projects.• Act as administrator of applications (SQL*LIMS, NWA, LIMSLink, Business Objects) supported within the organization. Mentor/train junior team members on specific business areas and systems.• Identify, analyze, propose and document appropriate solutions for problems and issues that may impact the project, acknowledging the broader business impact. Use technical tools (queries, process maps, etc.) for problem resolution.• Disseminate status, concerns, and solutions in a timely manner within the team and across functions, establish and maintaining relationships within the business or function.• Provide cross-functional and business knowledge to develop business system and process alternatives.

Deerfield, Illinois, Us

• Provided technical and operational support for LIMS, LIMSLink, and Northwest Analytical (NWA) systems, resolving system problems and proposing solutions to minimize and prevent recurring issues.• Mentored and trained others on the operation of LIMS, LIMSLink, and NWA systems.• Led or participated in medium to large size projects, own assigned tasks, produced detailed requirements and analyzed documents for assigned tasks. Partnered with business, quality, or other IT teams to complete work on-schedule and on-budget.• Participated in all phases of (SDLC) Systems development life-cycle (define requirements, code, test debug, and document) as well as analysis and system integration. Followed SDLC processes, application and quality validation for medium to large projects.• Assisted in developing test and validation requirements, preparing and documenting test data for complex systems.

Deerfield, Illinois, Us

• Conducted critical analyses on raw materials, initial, in-process and final products, and samples collected from the environmental monitoring programs at manufacturing facility. • Served as a mentor to associates providing training and work direction on a daily basis.• Reviewed test data, including documentation practices and performed release functions in LIMS and other systems.• Completed all testing, including special project / protocol testing in a timely and appropriate manner.• Maintained data integrity and ensured compliance with company SOPs and specifications.• Investigated deviations and wrote exception documents.• Participated in team functions, which impacted production, increased efficiency, solved problems, generated cost savings and improved quality.