Jesse Haskell Email & Phone Number

• Provide QTC review and approval of in-process tasks related to product and/or service provision.
• Generate, perform reviews, and maintain records of Validation Deliverables documentation and ensure compliance to procedures and processes.
• Maintain QTC documentation relevant to client-driven software product releases in QMS according with company procedures.
• Provide input on onboarding user materials and training, as assigned by management.
• Act as a general source of knowledge for endpoint’s internal Operations Software Development Life Cycle (SDLC) processes with regards to QTC product releases.
• Support Operations staff by: o Assisting staff to develop, write, and revise controlled Validation Deliverables.o Acting as a QTC representative and resource with regards to release of client-driven software product.

Branchburg, New Jersey, United States

-Responsible for ensuring that the receiving/inspection team receive and inspect tissueaccording to procedure and specification requirements to meet manufacturing timelines. -Provide leadership to the team with specific responsibility for motivating others, ensuring correctperformance of tasks, schedule work assignments, review of documentation, equipment.

Swiftwater, PA

• Ensure facilities, equipment and utility systems remain in a functional state and provide support services to allow laboratory personnel to focus on clinical testing activities
• Plan, manage and direct activities to ensure testing laboratories and equipment remain in a functional and GCLP compliant state
• Liaison between the testing laboratories and maintenance/metrology and applicable vendors when servicing/repairs are required
• Responsible to work with site services to schedule preventive maintenance and calibration activities, and be the primary contact to schedule repair services when functionality issues occur
• Responsible for vendor services scheduling, supply and, accountability
• Maintain, update, review, and author SOP's and facilities documents

• Spearheaded qualification of a multiplex ELISA for use in clinical studies which will increase analyst throughput 6-fold and writing corresponding reports
• Transferred Pneumo ELISA assay from ICH, London to Sanofi
• Extensive experience testing clinical assays including multiple ELISA’s, MSD multiplex, PRP-RIA, and Hep B
• Generate, review, and sign data collected for clinical studies and qualifications
• Author/Co-author SOP's and various documents to support lab functions

• Worked on a variety of Bioassays to contribute to vaccine performance monitoring
• Reviewed data and logbooks for accuracy and compliance
• Network across functions to assess needs and perform testing, review, training, and general lab work as needed outside of assigned group

• Established satellite laboratory by installing and qualifying new instrumentation, implementing lab procedures, creating workflow, and gaining accreditation on a two person team
• Analyzed and reported results using ISE, gravimetric calculation, spectrometry, and bacterial culture to determine plant efficacy, to help direct treatment processes and maintain state certification

• Aseptically plated specimens, performed gram staining, microbial isolation, identification, and susceptibility using Vitek II system
• Managed parasitology department and trained coworkers and interns
• Established micro department in Bagram, Afghanistan by ordering supplies, implementing Bactec culture machine, training hospital workers, and creating key codes for streamlined reporting in CHCS system
• Distinguished graduate of JBAIDS and M1M analyzer training courses and member of Bioterrorism response team

Bachelor Of Science (Bs), Biotechnology (Minor In Chemistry), 3.8 Gpa

Education record