This document provides a summary of Jasmine Hawk's experience and qualifications. She has over 16 years of experience in quality assurance and quality control roles in the biotechnology and pharmaceutical industries. Currently she works as a Quality Specialist at Merck Sharp & Dohme Corporation, where she oversees supply inspection and market package retention programs. Previously she has held QA roles with increasing responsibility at several other companies.
Talented and accomplished manufacturing professional with dedicated work ethic, equipped with more than 25 years of comprehensive achievements in quality assurance, safety, training and development, purchasing, inventory, process development, and project management.
Experienced, results-oriented professional with broad experience in pharmaceutical quality processes and problem solving. Expertise in reviewing complaints, SOPs, Batch Records, and other documentation for accuracy and completeness. Skilled in preparing for internal or external audits and correcting deficiencies. Demonstrated ability to bring new facilities into FDA compliance. Proficient in SAP and Trackwise. Areas of expertise:
PQMS | Batch Record Review | Controlled Substances | Document Control
FDA Regulations | Metrics Reporting | GMP / GLP, OSHA
Talented and accomplished manufacturing professional with dedicated work ethic, equipped with more than 25 years of comprehensive achievements in quality assurance, safety, training and development, purchasing, inventory, process development, and project management.
Experienced, results-oriented professional with broad experience in pharmaceutical quality processes and problem solving. Expertise in reviewing complaints, SOPs, Batch Records, and other documentation for accuracy and completeness. Skilled in preparing for internal or external audits and correcting deficiencies. Demonstrated ability to bring new facilities into FDA compliance. Proficient in SAP and Trackwise. Areas of expertise:
PQMS | Batch Record Review | Controlled Substances | Document Control
FDA Regulations | Metrics Reporting | GMP / GLP, OSHA
2. Jasmine Y. Hawk
Cell Phone (401) 5331364 205 Hampton Lake Drive
Email: HawkJasmine7@Gmail.com Rolesville, NC 27571
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 offshift
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 walkthrough audits and Operations for cGMP compliance.
● Assisted in implementing the 5S Lean manufacturing project in the manufacturing areas.
NEOSE Technologies Inc., Horsham, PA 20032005
Senior QC Associate, Microbiology Department
Performed microbiological assays including Bioburden, Sterility Check of InProcess 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 InProcess/ 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 IQOQPQ of the KQCL and Milliflex.
Covance Diosynth, Inc, Research Triangle Park, NC 20012003
QC Associate Microbiology
Performed microbiological assays including Bioburden, NonHost 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 PreApproval Inspection (PAI); Instituted FIFO system to organize the Cold
Room for QC; Served as the primary contact for Media Qualification.
Mercy Medical Center, Rockeville Centre, NY 19992001
Medical Microbiologist
Analyzed and reported microbial and fungal identifications and sensitivities of pathogenic
bacteria in throat, wound, sputum, urine, genital, stool, and blood cultures. Assisted with
phlebotomy.
Lab Corporation of America, Garden City, NY 19981999