Lilisa Knox

• Lead and assist implementation of cLABS LIMS system
• Organize and lead meetings, report status updates, and reviewing that reports are correct
• Making sure project is being done in a timely manner, working closely with key users implementing the system
• Understanding of QC processes, QC testing, strong quality systems and documentation background
• Making sure change controls are submitted, documents are being updated, and validating the LIMS system
• Some training for end users during GO LIVE
• Managed one project team in Agile environment, realizing success through application of SDLC methodologies and exceptional leadership skills.
• Created implementation methodologies to control project costs and meet deadlines.
• Streamlined project implementation by effectively coordinating cross-functional teams and resources.

• Company Overview: [BMS] (Spectraforce Technologies)
• Establish procedures for business processes based on global processes and specific workflows
• Support Master Data review for deployment in EM
• Function as EM system super user where applicable and track/maintain user metrics
• Assist with the development, implementation and deployment of training
• Troubleshoot issues, solve problems and assist with investigations and deviations with minimum guidance
• [BMS] (Spectraforce Technologies)
• Maintained up-to-date documentation of all LIMS-related procedures and processes to ensure compliance with industry regulations.
• Improved laboratory efficiency through effective implementation of LIMS workflows and protocols.

• Company Overview: (Select Source International)
• Act as a core team member responsible for coordinating and identifying Regulatory and Compliance Remediation activity plans related to product transfer
• Identify gaps and/or any misalignments found with batch records, test methods, method validation, regulatory files, etc.; presented data to team in weekly group meetings
• Drafting remediation plans and helping with identifying change controls
• Gathered data from multiple sources and summarized them into simple, well-organized documents
• Reviewed data and input data associated with appropriate molecule or drug
• Entered info into gQTS (Trackwise) to be routed for approval in DocuSign
• Routed forms for signatures along with attachments in DocuSign
• (Select Source International)
• Maintained up-to-date knowledge of regulatory changes, informing management of any potential impacts on company operations.
• Identified gaps in existing compliance processes and recommended updates.
• Developed risk assessment models to identify potential compliance risks.

• Company Overview: (Aequor Technologies)
• Complete instrument template spreadsheets with information from site source documents
• Test builds as part of the change control process for LIMS master data
• Identify correct product testing types from product specification
• Conduct validation testing and documentation using ALM-QC (Application Lifecycle Management Quality Center)
• Verify that master data is built per requirements
• Participate in development and/or revision of site and/or Standard Operating Procedures (SOPs)
• Build label templates and process changes for imprint plates, roll labels, enclosures, films, and overwraps into Pfizer template
• Responsible for Master Data configurations, analysis, assessment, testing, and documentation within gLIMS
• (Aequor Technologies)
• Improved team collaboration by initiating regular coordination meetings.
• Streamlined project workflows for enhanced efficiency, adopting agile methodologies.
• Volunteered for extra shifts during holidays and other busy periods to alleviate staffing shortages.

• Research and execute food safety related projects as well as develop and execute new test procedures in order to evaluate procedures used by customers
• Perform audits or inspections of assigned areas or systems to assess compliance with regulatory and company standards as part of a team
• Communicates and resolves audit comments with client areas
• Issue reports summarizing deficiencies and work with areas to execute remedial action
• Independently planned and performed work under limited supervision; also develop/adapt procedures, format specific objectives and solve problems
• Analyze data make and record educated and detailed observations, as well as problem solve and create solutions

• Responsible for growth performance in product testing of the BacT/Alert product lines for mycobacteria, which was performed in a BSL-2 & BSL-3 laboratory
• Performed stability testing on finished product for mycobacteria, which includes the BCG strain
• Performed sterility testing on antibiotic supplement and reconstitution fluid
• Performed some Environmental Monitoring testing (bioburden, water sampling, endotoxins, etc.)
• Maintained and freeze mycobacteria & micro bacteria organisms/cultures for testing in BSL-3 laboratory
• Transferred data from BacT view into LIMS system
• Assisted QA in performing batch records review, and trained individuals on scientific software as well as documentation and BSL-3 level practices & procedures
• Responsible for departmental ordering through SAP system
• Operated the Vitek system, and frequent use of the spectrophotometer & microscopy
• Assisted in some research and development projects for mycobacteria, as well as method/equipment validation for new lab
• Generated month end reports done on performance in the lab; assisted with SOP revisions
• Sub cultured mycobacteria and microorganisms with aseptic techniques; identified non-mycobacteria flora using manual gram staining technique
• Wrote and conducted OOS/deviation investigations related to growth performance test failures
• Improved overall production efficiency by identifying and resolving quality control issues.
• Enhanced product quality by conducting thorough analyses and implementing corrective actions.
• Maintained a safe working environment, adhering to safety regulations and proper handling of hazardous materials.
• Conducted root cause analysis for recurring issues, developing long-term solutions to prevent recurrence.
• Developed comprehensive documentation, maintaining accurate records of quality control results and actions taken.
• Provided training to new hires on quality control procedures, fostering a culture of excellence within the team.
• Interpreted test results by comparing to established specifications and control limits, making recommendations on appropriateness of data for release.
• Documented and executed detailed test plans and test cases and summarized and logged audit findings for reporting purposes.
• Collected and analyzed data to measure effectiveness of quality control processes.

Worked in the Microbiology Department.

• Trained junior technologists on proper laboratory techniques, fostering a culture of teamwork and collaboration.
• Enhanced the accuracy of test results by regularly calibrating and maintaining laboratory equipment.
• Performed troubleshooting on sophisticated instruments to maintain optimal functionality while minimizing downtime in the lab setting.
• Ensured compliance with safety regulations through regular inspections and adherence to established guidelines within the lab environment.
• Mentored junior staff members, sharing expertise in various laboratory techniques and inspiring professional growth.
• Gathered laboratory samples, monitored fluids and read test results to make accurate care decisions.
• Recorded and interpreted laboratory results to present to senior colleagues.
• Conducted and reported on microbiological, serological and chemical analysis on clinical and environmental samples.

• Worked in the Chemistry Department.
• Gathered laboratory samples, monitored fluids and read test results to make accurate care decisions.
• Conducted and reported on microbiological, serological and chemical analysis on clinical and environmental samples.
• Prepared and validated buffers and in-house reagents, calibrators, and controls in advance of laboratory testing and analysis orders.

• Supervised employee team of 40+ in a poultry plant
• Responsible for ensuring that standard yields were met, maximizing efficiency, and controlling overtime and material costs
• Maintained product quality specifications while staying within the OSHA and HAACP/SOP and cGMP guidelines
• Resolved issues quickly to maintain productivity goals.
• Coordinated with other departments to maintain smooth and efficient product flow.
• Improved product quality by monitoring production processes, conducting inspections, and initiating corrective actions as needed.
• Implemented safety protocols and conducted regular audits, achieving a reduction in workplace accidents and incidents.
• Enhanced production efficiency by implementing lean manufacturing techniques and reducing waste.
• Maintained accurate documentation of production data, enabling informed decision-making for process improvements.
• Trained staff of direct labor employees to perform assembly and manufacture of specified products.
• Conducted performance reviews each quarter, offering praise and recommendations for improvement.

• Tested HLA and DNA Samples with sputum, blood, and tissue samples.
• Efficiently processed a high volume of samples daily, supporting rapid diagnosis for patients and healthcare providers alike.
• Gathered laboratory samples, monitored fluids and read test results to make accurate care decisions.
• Developed strong working relationships with colleagues from different departments, fostering collaboration towards shared goals.
• Reduced error rates in test results by maintaining equipment calibration and conducting rigorous quality control checks.
• Recorded and interpreted laboratory results to present to senior colleagues.
• Trained new Laboratory Technologists on best practices and standard operating procedures, ensuring consistent team performance.