Summary
Overview
Work History
Education
Skills
Timeline
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Amy Curiel

Amy Curiel

Newton,KS

Summary

Experienced and dedicated professional with 14 years of diverse experience in multiple roles within FDA registered 503B Outsourcing Facility and cGMP Pharmaceutical Manufacturing. Skilled and motivated leader trained in high-risk sterile compounding and an expert in aseptic technique. Demonstrated ability to creatively solve problems and develop advantageous organizational solutions. Proven track record of maintaining exceptional quality and product quantity standards. Actively serves as a leader and mentor, showcasing a team-focused approach that fosters cohesiveness. Core competencies include leading and coordinating quality investigations, resolving issues, implementing corrective actions, developing and mentoring quality teams, and supporting production and customer needs. Passionate about continuous learning, applying best practices, and driving for change. Committed to delivering safe and effective products that improve the lives of patients and customers.

Overview

13
13
years of professional experience

Work History

Site Quality Authority – Biological Quality

Pfizer
10.2019 - 10.2024
  • Reduced the backlog of 120 investigations to 80 investigations for Biological Quality team within 6 months.
  • Suggest improvements and conduct continuous improvement activities.
  • Independently assess wide range of Change Control activities to determine potential Quality and Operation Good Manufacturing Practice impacts.
  • Maintain regulatory compliance in accordance with current Good Manufacturing Practices.
  • Offer support to investigators to ensure true root cause is identified and effective CAPAs are put in place.
  • Drives outside of the box solutions that challenge the status quo.

Quality Assurance Investigator

AGC Biologics
08.2023 - 05.2024
    • Performed root cause analysis to identify and resolve defects, improving quality standards.
    • Communicated with production team members about quality issues.
    • Decreased the investigation backlog from over 800 to no backlog and less than 200 investigations.
    • Reported repeated issues to supervisors and other departments, collaborating to identify issue roots and rectify problems.
    • Started as a contractor and converted to FTE after 11 months.

Batch Release Manager

Pfizer
01.2017 - 10.2019
    • Reduced the overall review backlog from over 100 to clean slate within 7 months.
    • The team then maintained a one (1) week turn around for first reviews
    • An active member in the launch of AMPS, SAP, and serialization to ensure all processes were able to be completed without any delays to the release process
    • Develop goals and objectives for each team member and provide direction and growth for each of them
    • Offered continued support to production to resolve issues identified during the review process
    • Lead and provide oversite to a team of 18 for all batch release activities.

Senior Quality Manager

SCA Pharmaceuticals
01.2016 - 12.2016
  • Assured compliance with all Boards of Pharmacy, DEA, and FDA regulations
  • Provided leadership, direction, and coordinated all quality activities in accordance with the policies, goals and objectives of the company
  • Made decisions regarding quality control and compliance for all batches and products
  • Led all customer and regulatory audits
  • Was a contributing member of the leadership team and engaged in business decisions from the Quality perspective.
  • Mentored and encouraged employees to strive for excellence while fostering professional growth.

Quality Engineer Senior Supervisor

Hospira
07.2015 - 01.2016
  • Supervised and trained a team of 12 Quality Engineers as direct reports and a QE Supervisor with an additional 4 direct reports.
  • Experienced a 65% reduction in human related exceptions reports in 4 months in the Vials Business Unit.
  • In the first two months in the role, aided in a 20% decrease in cycle time and decreased the aging backlog by 58%.
  • All investigations relating to batch release were completed on time with no late releases due to open investigations.

Quality Engineer Supervisor for Engineering / Validation

Hospira
06.2013 - 07.2015
  • Led investigators for engineering, validation, facilities and miscellaneous exception report
  • Responsible for performing low, medium, and high-level investigations
  • Produced high quality and in-depth investigations
  • Demonstrated organizational and negotiation skills along with the ability to prioritize and deliver on multiple complex tasks
  • Proven ability to work independently as well as perform as a team member and leader
  • In one year through root cause analysis and effective Corrective and Preventive Actions the team decreased the number of medium and high-level investigations by 53% in the validation and engineering departments.

Quality Engineer

Hospira
11.2011 - 06.2013
  • Performed in-depth root cause investigations related to manufacturing validation, and non-marketed complaints
  • Utilize "Define, Measure, Analyze, Improve and Control" (DMAIC) process to identify scope, perform root cause analysis and identify effective CAPAs.
  • Evaluate existing CAPAs and effectiveness checks to ensure each one properly addressed root cause.
  • For environmental monitoring excursions, assess potential impact of the recovered organism based on microbial identification. Assess environmental monitoring data and trends, as well as review the maintenance logs for equipment, facilities, HVAC and the cleaning/sanitization of the potentially contaminated areas to determine the potential source and impact of the organism.

Education

Bachelor of Science - Biology

Wichita State University
Wichita, KS
05-2008

Skills

  • Sterile/Aseptic Techniques
  • Knowledge of 503B High Risk Sterile Compounding and USP requirements
  • 21 CFR/cGMP Guidelines
  • Deviation/CAPA Management
  • Technical Writing / SOP Development
  • FDA/DEA
  • Media Fill/Operation Qualification
  • Root Cause Analysis/Quality Investigations/DMAIC
  • Process Improvements to Streamline Activities
  • Leadership Skills/Team-building
  • SAP/TrackWise/MODA/QMS
  • Batch Record Review/Batch Release

Timeline

Quality Assurance Investigator

AGC Biologics
08.2023 - 05.2024

Site Quality Authority – Biological Quality

Pfizer
10.2019 - 10.2024

Batch Release Manager

Pfizer
01.2017 - 10.2019

Senior Quality Manager

SCA Pharmaceuticals
01.2016 - 12.2016

Quality Engineer Senior Supervisor

Hospira
07.2015 - 01.2016

Quality Engineer Supervisor for Engineering / Validation

Hospira
06.2013 - 07.2015

Quality Engineer

Hospira
11.2011 - 06.2013

Bachelor of Science - Biology

Wichita State University
Amy Curiel