Jasmine Hawk Email & Phone Number

Coram, Ny, Us

Coram, Ny, Us

Shirley, New York

Raleigh-Durham, North Carolina Area

Current Merck Role: Subject Matter Expert in the Supplies Inspection Department/Incoming Components for Merck in the Durham Facility. 1- Coordinate incoming component testing among my team to support the Planning and Manufacturing Areas.2- Durham Liaison for sister site testing alignment and defect categorizing efforts.3- Provide Technical Support for incoming component investigations and CAPAs with corresponding internal and external groups as well as with the corresponding vendors for resolution of issues.4- Train and Qualify incoming personnel.5- Revise Training Qualifications, Testing Modules and site procedures.6- Provide feedback from the Durham Facility for Global Document revisions as it pertains to incoming disposition of components.7- Maintain multiple internal metrics and provide feedback and escalations to management.8- Maintain the current Tracking Database for incoming components and schedule departmental testing in a FIFO manner.9- Durham Liaison for incoming component vendor visits and for-cause meetings. 10 - Responsible for maintaining the area inspection ready at all times.11- Responsible for maintaining Retain Samples for corresponding incoming components.12- Responsible for creating GLIMS Retain sample locations.Previous Experience: SAP Investigation/CAPA Coordinator for the Quality Laboratory. Primary author and SAP Coordinator of the investigations from the Environmental Monitoring Laboratory Department.Subject Matter Expert on multiple EM Laboratory Assays and training incoming personnel. Subject Matter Expert on Laboratory Method Qualifications - Bioburden and EndotoxinTechnical Writer - Compliance Protocol Writer.Change Control owner and trainer.

Raleigh-Durham, North Carolina Area

PROFESSIONAL EXPERIENCEMerck Sharp & Dohme Corporation, Durham, NC 2009-PresentQuality Specialist, Quality Operations LaboratoriesProvided QA support for Investigations/ CAPAs for the Quality Operations (QO) Laboratories. • Sub-system owner / manage Supplies Inspection and support the Market Package Retention Program• Served as the Investigation/ CAPA Coordinator in SAP for the Environmental Monitoring (EM) Laboratory. Authoring the majority of the investigations for the entire EM Lab team.• Proficient at testing and approving EM Lab: Media Bioburden, Facility Water Filtration, TOC, LAL, Color and Conductivity, Growth Promotion, shipping of samples and Read/ Approve EM samples. • Qualified Reader for Vial and Process Simulation samples. • Gas Identity Testing SME.• Qualified Walk-Through Auditor.• Authored several compliance study protocols to challenge the existing SOPs and the VITEK Protocol.• Served as a cross departmental Logbook Coordinator in VMF. • Performed VMF 101 EM and Utilities Sampling (Routine and Per Process)• Performed several LIMS Change Requests for VMF 101 samples.• Worked with WP Regulatory Compliance group to Change the 5.0µm particle Action Level specification from 1 particle/m3 to 20 particles/m3 and the Alert Level specification from "Not Applicable" to 10 partilcles/m3 for all Grade A classified areas.• Revised SOPs.• Performed the Method Qualifications for all VBF Media Bioburden samples with troubleshooting several Time Holds outside of protocol.• Served as the scriber for Divisional Audits.

Amgen Inc, West Greenwich, Ri

Amgen Inc, West Greenwich, RI 2005-2007Quality Assurance Facilities Support Specialist, (QAFS) Responsible for facility and utilities related Change Controls, Nonconformance investigations, Facility EM Trending, Work Orders and Validation Protocols.• BAS/ BMS Quality Alarm Responding, QA Approval of Work Orders, provided off-shift coverage, responded to OOS EM results, assisted in EM and Utilities trending of data and review of facility related validation protocols.• QA Approver/ Owner of Class 1, 2, 3 Facility and Engineering related investigations and CAPAs. • Served as a mentor to junior personnel regarding projects. • Designed and Implemented the QAFS Regulatory Assessment Project for the entire team.• Performed manufacturing facility walk-through audits and Operations for cGMP compliance.• Assisted in implementing the 5S Lean manufacturing project in the manufacturing areas.

Horsham Pa

NEOSE Technologies Inc., Horsham, PA 2003-2005Senior QC Associate, Microbiology Department Performed microbiological assays including Bioburden, Sterility Check of In-Process media, Qualification of incoming media/ reagents and microbial identifications. Authored Method Qualification Protocols and Equipment Performance Qualifications.• Served as a primary point of contact for Endotoxin testing of In-Process and Facility water samples.• Assisted in peer review of laboratory data.• Performed EM sampling and water collection.• Revised procedures.• Developed and executed Method Qualification Protocols for Endotoxin and Bioburden Analysis of Final Fill Material. • Assisted with new laboratory equipment IQ\OQ\PQ of the KQCL and Milliflex. Covance - Diosynth, Inc, Research Triangle Park, NC 2001-2003QC Associate Microbiology Performed microbiological assays including Bioburden, Non-Host Contamination Assay, Microbial Identification, Qualification of incoming media/ supplies, Host Viability Concentration, Method Qualification and Purity Assays• Served as a primary contact for the execution of Microbial Limits Testing and Validation. • Oversaw QC testing of incoming media, VITEK cards and reagents.• BI Testing• Managed all the Microbial Identification testing of all Utilities and EM sampling and multiple contracting clients. • Executed the majority of the client product Bioburden Method Qualifications and experiments with collaboration from the Manager and Director of Microbiology.• Developed a Stock Culture Maintenance Program in collaboration with senior team members. • Assisted in Pre-Approval Inspection (PAI). • Instituted FIFO system to organize the Cold Room for QC.• Served as the primary contact for Media Qualification.

Raleigh-Durham, North Carolina Area

Covance - Diosynth, Inc, Research Triangle Park, NC 2001-2003QC Associate Microbiology Performed microbiological assays including Bioburden, Non-Host Contamination Assay, Microbial Identification, Qualification of incoming media/ supplies, Host Viability Concentration, Method Qualification and Purity Assays• Served as a primary contact for the execution of Microbial Limits Testing and Validation. • Oversaw QC testing of incoming media, VITEK cards and reagents.• BI Testing• Managed all the Microbial Identification testing of all Utilities and EM sampling and multiple contracting clients. • Executed the majority of the client product Bioburden Method Qualifications and experiments with collaboration from the Manager and Director of Microbiology.• Developed a Stock Culture Maintenance Program in collaboration with senior team members. • Assisted in Pre-Approval Inspection (PAI). • Instituted FIFO system to organize the Cold Room for QC.• Served as the primary contact for Media Qualification.

Incomplete Ms, Quality Assurance/ Regulatory Affairs In Pharmaceutical, 4.0

This is a Masters Program in QA/RA in the Pharmaceutical Industry. Degree not pursued, the certificate to QA/RA was in scope.

Medical Laboratory Technology, Clinical Laboratory Science/Medical Technology/Technologist

Associate'S Degree, Science And Mathematics