Laney Rush Email & Phone Number

Durham, Nc

Marietta, Georgia

• Provide oversight and conduct of a project throughout its life at Q2 Solutions, including method development, method validation, and sample analysis. • Serve as Principal Investigator for GLP studies. • Work closely with Technical Writing and QA to ensure projects are completed on schedule. • Review validation and bioanalytical reports for completeness. • Maintain all communication with customers providing daily updates on all active projects while being vigilant for opportunities to earn additional business. • Work with the customer to resolve sample discrepancies. • Monitor the progress of all assigned projects and alert management if work falls behind schedule. • Provide regular project status updates to management. • Participate in weekly scheduling and revenue update meetings and provide updates on project progress. • Submit accurate weekly assessment of resource requirements for scheduling purposes • Prepare validation and sample analysis plans. • Review data (run binders, data tables, etc) for regulatory compliance and scientific quality. • Address issues from QC and QA review for run binders. • Conduct thorough investigations of all failed runs. • Lead method troubleshooting investigations. Assemble group of pertinent technical resources and write up investigation report. • Provide project trackers for client communications and lead regular teleconferences to discuss project progress • Coordinate customer visits. • Visit customers. • Work with business development staff to prepare quotes for assigned customers. • Approve validation experimental designs. • Prepare data for external presentations. • Ensure projects are archived in accordance with Quintiles SOP. • Comply with all applicable regulatory standards, including GCP and GLP.• As Group Lead, identify intra- and inter- departmental process gaps. Create solutions and implement through training and updating SOPs, Work Instructions, and Job Aides.

Marietta, Ga

• Provide oversight and conduct of a project throughout its life at Quintiles, including method development, method validation, and sample analysis.• Serve as Principal Investigator for GLP studies.• Work closely with Technical Writing and QA to ensure projects are completed on schedule.• Review validation and bioanalytical reports for completeness.• Maintain all communication with customers providing daily updates on all active projects.• Work with the customer to resolve sample discrepancies.• Monitor the progress of all assigned projects and alert management if work falls behind schedule.• Provide regular project status updates to management.• Submit accurate weekly assessment of resource requirements for scheduling purposes.• Prepare validation and sample analysis plans.• Review data (run binders, data tables, etc) for regulatory compliance and scientific quality.• Address issues from QC and QA review for run binders.• Conduct thorough investigations of all failed runs.• Organize method troubleshooting investigations. Assemble group of pertinent technical resources and write up investigation report..• Coordinate customer visits.• Visit customers.• Work with business development staff to prepare quotes for assigned customers.• Approve validation experimental designs.• Prepare data for external presentations.• Ensure projects are archived in accordance with Quintiles SOP.• Comply with all applicable regulatory standards, including Good Clinical and Good Laboratory Practices.

Marietta, Ga

With close direction from the Director, BioServices, BioServices Project Manager, BioServices Project Leader 2, the BioServices Project Leader 1 will:• Plan day to day activities for assigned projects.• Create work lists for wet lab staff.• Request samples from Laboratory Operations for analysis• Provide daily direction and feedback to Wet Lab staff.• Import and process run data in Watson. Accept or reject run results.• Work with Project Manager to investigate failed runs and runs with analytical issues.• Write up analytical results and assemble run binders.• Submit accurate weekly assessment of resource requirements for scheduling purposes• Attend weekly scheduling and revenue update meetings and provide updates on project progress• Maintain run trackers for assigned projects.• Provide timely MS timesheets for study tracking• Review data (run binders, data tables, etc) for regulatory compliance and scientific quality.• Track supply and expiration of project related materials (reference compounds, stock solutions, etc).• Assemble data tables for client submission• Design validation experiments to direct wet lab staff.• Archive all studies in a timely manner in accordance with Quintiles SOP.

Roswell, Georgia

I fulfill various duties and serve many roles ranging from production, inventory and distribution, receiving, quality, project team member, and development liaison. When first coming on board, I assisted with a manufacturing transfer from California to Georgia within a matter of months that passed all external audits including notified bodies (DEKRA and BSI). Since then I have participated in at least 4 external audits and annual internal inventory audits. As a production associate, I issue and review Work Orders (Lot History Records) for accuracy and component/product traceability. I also assemble devices in accordance to approved Standard Operating Procedures including label printing and final packaging. Additionally, I track monthly sales of all commercially available products and schedule production builds accordingly, including initiating jobs in our ERP system, issuing materials using FIFO logic, and receiving the finished product into inventory. Finally, I have written and revised various Standard Operating Procedures for Production and Quality.In an inventory management role, I process incoming products and materials in the ERP system as well as perform incoming inspections as necessary in accordance to Quality SOP's as well as processing customer returns and their corresponding paperwork and inspections.In the distribution role, I prepare both the paperwork and product for both international and domestic shipment including entry into AESDirect and all approved carriers (FedEx, UPS, DHL).As a project team member, I have participated with the development of new devices from the Operations side including packaging, shipping, manufacturing transfer, verification and validation, and pFMEA.I have worked with Research and Development to transfer newly designed products to manufacturing and production while increasing efficiency and minimizing failure rates.

Perform analytical testing of reagents, raw materials, and products to ensure accurate manufacturing and a quality product using many USP methods.GDP, GLP and ISO compliant.

Marietta, Ga

Assist in process design and development of cell growth procedures. I also perform numerous laboratory assays such as RNA isolation, PCR, and Protein Surface Marker assays for product I.D. and production support. Adept at aseptic technique, GMP, GLP, and GDP.

Experienced in aseptic processing of samples in a clean room under GLP/GMP laboratory practicesTest the sterility of samples using immersion, membrane filtration and fluid path fill techniquesSkilled in handling samples of a potentially hazardous nature including human tissue, biological samples, and pharmaceuticalsDuties include performing interim preliminary reads of samples in incubation, multi-weekly visual inspection of samples in incubation to check for growth, approving samples for release to clients for use

Achieved green inventory scores and was responsible for returns, recalls, and orderingQuickly and accurately received, input, filled, and released prescriptionsTrained in HIPPA complianceExcellent customer serviceAbility to prioritize job duties and multitaskAssist in internal store audits of prescription records and controlled medications

Biochemistry, Biochemistry

Education record

Activities and Societies: Orchestra