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 releases. o Promoting adherence to compliance procedures associated with the release of client systems and operations product templates.

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 and area preparation and provide effective administration of procedures and review of work. -Provide technical support to Receiving Inspector I, II’s and III’s and cross-functional teams to ensure effective operations. -Ensure proper equipment functionality and appropriate levels of supplies. -Supports and partners with cross-functional teams to resolve any issues or non-conformance encountered. -Assist in documentation updates and related change controls activities as needed and perform applicable actions for Nonconformance Reports (NCRs), Supplier NCRs, Change Controls, etc.-Manages the functions of the group without direct supervision.

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