Summary
Overview
Work History
Education
Skills
Timeline
Generic

Courtney Drost

Summary

A highly meticulously detailed oriented and organized quality assurance professional dedicated to identifying deficiencies and initiating solutions for quality processes and operations. Strong interpersonal skills with success in supporting all departments committed to ensuring quality and regulatory standards are met. Seeking employment that offers professional challenges utilizing problem solving and interpersonal skills as well as promoting growth.

Overview

5
5
years of professional experience

Work History

Quality Assurance Complaints

Aurobindo Pharma USA
02.2022 - Current
  • Initiate, receive, and process product complaints to their respective manufacturing units and to business Contract Manufacturing Organizations.
  • Perform all necessary communication and filing with complainants for the manufacturing units.
  • Receive and ship all complaint samples for investigation analysis.
  • Review final manufacturing investigations to ensure accuracy and provide closure letters to appropriate parties.
  • Assist in processing Field Alert Submissions to the FDA.
  • Aid Pharmacovigilance Department in handling medical inquires, intake and processing adverse events, and recalls.
  • Perform monthly metrics and reconciliations for trend analysis.
  • Assist in maintaining quality systems; CAPA's, change control, deviations, product quality review, and quality assurance policies and procedures.
  • Collaborate with QA team in writing, reviewing, and implementing SOP's.
  • Work with all cross functional departments to identify, resolve, quality issues and improve product reliability and customer satisfaction.
  • Assist with new hire trainings in QA department.

Quality Assurance Intern

ACP Pharmaceuticals
01.2020 - 04.2021
  • Assisted in developing QA processes for more efficient and accurate testing procedures.
  • Apply use of good laboratory practices for analytical methods of testing, validation testing, data analysis, stability programs, and sampling programs.
  • Review contamination control procedures for cleaning/sterilization, premises, cleanrooms and environmental monitoring.
  • Assist in validation master plans and qualification of equipment.
  • Perform Root Cause analysis for manufacturing operations.
  • Collaborate with Quality Control team in reviewing sterilization reports in compliance with good aseptic practices.

Graduate Program Field Work

AstraZeneca
01.2019 - 12.2019
  • Review quality and GMP compliance agreements against local, national, and global quality standards and regulatory requirements.
  • Asses effectiveness of requirements for pharmaceutical manufacturing operations through identifying and implementing CAPA's.
  • Apply risk based approach to planning and conducting audits using Good Auditing Practices.
  • Assis in risk management models for risk identification, risk analysis, risk evaluation and risk control for pharmaceutical operations.

Education

Bachelor of Science -

Temple University
Philadelphia, PA

Graduate Diploma - Good Manufacturing Practice

University of Technology Sydney

Skills

  • Advanced IT skills (Microsoft, Excel)
  • Quality Guidelines for pharmaceutical, medical device, and cosmetics manufacturing; ICH, PICS, WHO, ISO Standards
  • Regulatory Governing Body guidelines domestic and international ( FDA, EMA, TGA)
  • Exceptional written, listening, and verbal communication skills and phone etiquette
  • Critical and analytical problem solving skill sets
  • Excellent interpersonal skills with ability to work efficiently on teams or independently with effective decision making
  • Adaptability, Organization Skills, Attention to Detail, and time management abilities
  • Safety and Risk Management Protocols
  • Proficient in Quality Management Software

Timeline

Quality Assurance Complaints

Aurobindo Pharma USA
02.2022 - Current

Quality Assurance Intern

ACP Pharmaceuticals
01.2020 - 04.2021

Graduate Program Field Work

AstraZeneca
01.2019 - 12.2019

Bachelor of Science -

Temple University

Graduate Diploma - Good Manufacturing Practice

University of Technology Sydney
Courtney Drost