Summary
Overview
Work History
Education
Skills
Timeline
Generic

Ashley Melvin

Rocky Mount ,NC

Summary

Enthusiastic, hardworking professional with 7 plus years of pharmaceutical experience seeking to obtain a challenging position providing professional career growth in the pharmaceutical industry.

Overview

12
12
years of professional experience

Work History

Senior Validation Engineer

Pfizer
Rocky Mount, NC
01.2021 - Current
  • Ensure compliance of existing Direct Level I and II equipment through Periodic Performance Qualifications (PPQs).
  • Oversee all activites for PPQs including scheduling, execution and data review to ensure all acceptance criteria are met.
  • Manage PPQ deviations in QTS.
  • Provide oversight to Engineers, Associate Engineers and Technicians.
  • Participate in developments/improvements to validation programs as needed to remain current with cGMPs and industry standards.
  • Responsible for continuous process improvements for the Compliance Validation Department

Validation Engineer

Pfizer
Rocky Mount, NC
09.2018 - 01.2021
  • Ensure compliance of existing Direct Level I and II equipment through Periodic Performance Qualifications (PPQs) and Periodic Reviews.
  • Oversee Associate Engineers and Technicians.
  • Participate in developments/improvements to validation programs as needed to remain current with cGMPs and industry standards.

Associate Validation Engineer

Pfizer
Rocky Mount, NC
07.2017 - 09.2018
  • Ensure compliance of existing equipment, processes, facilities, and computer systems by performing Periodic Reviews.
  • Complete Periodic Performance Qualifications (PPQs) on existing laboratory equipment.
  • Participate in developments/improvements to validation programs as needed to remain current with cGMPs and industry standards.

Manufacturing Quality Engineer

Hospira, A Pfizer Company
Rocky Mount, NC
07.2015 - 07.2017
  • Responsible for providing oversight and guidance in manufacturing operations as well as ensuring continuous facility and GMP compliance.
  • Coach manufacturing personnel on proper GMP and SOP compliance, including aseptic technique and empowering them to identify and escalate quality issues to ensure product quality
  • Duties also include reviewing in-process batch records, restricting product using multiple platforms, initiate CAPAs and review/approve manufacturing operational decisions

Environmental Control Analyst

Kelly Services / Hospira
Rocky Mount, NC
10.2013 - 07.2014
  • Collected assays, interpreted and reported results of microbiological testing of manufacturing environments in order to assure proposed products are manufactured in a validated environment in which established cleanliness levels are maintained.
  • Performed routine testing of in-process and finished products.
  • Maintained accurate records of all testing performed and entered laboratory test data into the Laboratory Information Management System.

Education

Bachelor of Science - Animal Science

North Carolina State
05.2012

Skills

  • Trackwise / QTS
  • Aseptic Technique
  • Aseptic Processing
  • Sterilization
  • cGMP
  • Project Management
  • Fast Learner
  • Organized
  • Problem Solving
  • Self-Motivated
  • Team Work

Timeline

Senior Validation Engineer

Pfizer
01.2021 - Current

Validation Engineer

Pfizer
09.2018 - 01.2021

Associate Validation Engineer

Pfizer
07.2017 - 09.2018

Manufacturing Quality Engineer

Hospira, A Pfizer Company
07.2015 - 07.2017

Environmental Control Analyst

Kelly Services / Hospira
10.2013 - 07.2014

Bachelor of Science - Animal Science

North Carolina State

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