Summary
Overview
Work History
Education
Skills
Accomplishments
Affiliations
Certification
Timeline
Generic

Evelyn Henry

O'Fallon

Summary

Results-driven Quality Assurance Specialist with over 20 years of experience in the medical device industry. Known for exceptional discretion, quality management, and performance analysis. Skilled in training new hires, retraining employees, and ensuring accuracy across all products. Proven track record in strategic planning, process improvement, and standards implementation to drive sustainable company growth. Regulatory Affairs Specialist with 5+ years of expertise in compliance management and navigating complex regulatory landscapes. Strong collaborator with a focus on effective team communication and delivering results. Proficient in Microsoft Word, Excel, PowerPoint, Project Management, and Quality Management Systems (QMS). Adept at regulatory submissions, risk management, and policy development.

Overview

28
28
years of professional experience
1
1
Certification

Work History

Senior Regulatory Affairs Associate

Amgen (contractor for Ampcus)
06.2022 - Current
  • Provides varying levels of product support to the regulatory Chemistry, Manufacturing, and Controls (CMC) department, across regions and phases of development.
  • Manager program (products) for Amgen Contract Manufacturing (CMO).
  • Support includes assessing changes for regulatory reportability and organizing, managing, and executing regulatory CMC projects in support of regulatory submissions.
  • Assisted in the development of labeling content by working closely with marketing teams, guaranteeing adherence to regulatory guidelines.
  • Provided expert guidance on interpretation of clinical trial data for inclusion in regulatory submissions, showing strong analytical skills.
  • Managed Amgen's program for Pivotal Clinical Trial phases, transitioning to Commercial product.

Senior Complaint Investigator

Meridian Medical Technologies (A Pfizer Company)
06.2020 - 03.2021
  • Understand customer/patient use of and manufacturing processes for the site manufactured, packages, and/or distributed products.
  • Track receipt, investigation, and closure of product complaints to ensure adherence to established timelines.
  • Investigate complaints and subsequently document the evaluation actions taken and conclusions reached using the defined report template.
  • Where possible identify the root cause of the complaint and facilitate identification and implementation of corrective and preventive actions relative to a complaint investigation.
  • Submit Quality Notification Reports to site management for expedited complaints.
  • Track and trend complaints, including the provision of trend reviews/reports to customer, site, and corporate management, and for Annual Product Records Reviews.

Compliance Investigator

Meridian Medical Technologies (A Pfizer Company)
07.2019 - 05.2020
  • Remain up to date on current Regulatory trends (Regulatory Observations, New Regulations / Guidelines) as well as Meridian’s Quality Standards. Communicate to the network key learnings at any of our sites through a regulatory audit or emerging regulations. Input could be from the internal network (inspections, complaints, internal audits) or external regulatory agencies.
  • Oversee regulatory commitments and health authority queries. Assist with draft responses to audit observations.
  • Work with Pfizer Global Supply groups as needed.
  • Work with Site Pest Control and submit reports to the appropriate departments.
  • Perform other duties within the quality department as required.

Regulatory Affairs Associate

Titan Spine LLC
04.2018 - 04.2019
  • Managed and led the Corrective /Preventive Action (CAPA) Program.
  • Achieved departmental goals and objectives by instituting new processes and standards for the CAPA process.
  • Configured (designed) / implemented a platform (module) CAPA process in a cloud-based software QT9 Quality Management System (QMS). This electronic process replaced the paper-based CAPA process.
  • Technical writing of quality / regulatory documentation and implementing these documents.
  • Revised the Information for Use (IFU), and worked with printer and translator vendors for the final version of IFU.
  • Listing and registration of Titan Spine medical devices (products) in the FDA FURLS database.
  • Assign Global Trade Item Number (GTIN) to be further assigned in the GS1 Us database.
  • Compiled and maintained regulatory documentation databases and systems and technical writing of policies and procedures.

Regulatory Affairs Specialist (Contractor)

Curium Pharmaceutical LLC
02.2017 - 02.2018
  • Provided regulatory support and authored FDA regulatory submissions for Annual Reports on New Drug Application (NDA) and Drug Master Files (DMF) for imaging drugs.
  • Created dossier for Chemistry, Manufacturing, and Controls (CMC) to ensure timely regulatory filings using the FDA-required Electronic Common Technical Document (eCTD) submission format.
  • Monitored regulatory change required by new and revised laws and regulations, communicating complex protocols and determining operational impacts.
  • Collaborated with the Quality, manufacturing, and Marketing teams of North America Imaging products and Subject Matter Expert (SME) for Advertising and Promotional material submitted to the FDA.
  • Developed and organized Ad-Promotional Regulatory submissions for required working designs and specifications.

Complaint Investigator

Aesculap Inc.
07.2015 - 01.2017
  • Support the Aesculap Quality Assurance Complaint team for complaint investigations resulting from non-conformance events and development of appropriate remediation/CAPA plans.
  • Completion of the investigation activities in the most efficient manner and driving the investigation for root cause determination is critical. Track and trend the investigation process.
  • Evaluated complaints identified as FDA reportable as Medical Device Reporting (MDR), were filed with the FDA using the FDA eSubmitter electronic system. To ensure the complaints are reported in a timely and uniform manner as required by the FDA 21 CFR part 820.198.
  • Perform visual evaluation of complaint samples returned from customers or distributors. Logged product information about the complaint into the SAP database system as part of the evaluation process.
  • Revising standard operating procedure (SOP) and work instructions (WI). Created new job aides (WI) for new hires.

Complaint Investigator (Contractor)

Virbac Corporation
02.2015 - 05.2015
  • Support the Virbac Quality Assurance Operations team with complaint investigations resulting from non-conformance events and the development of appropriate remediation/CAPA plans.
  • Completion of the investigation activities in the most efficient manner and driving the investigation for root cause determination was critical to the success of the project. Track and trend the investigation process.
  • Elevate confirmed complaints to Pharmacovigilance using the Pharmaceutical Vigilance (PV) work system and taking photographs of samples as part of the evaluation process.
  • Revised procedures for the Quality Assurance team.

Quality Assurance Coordinator II (Contractor)

Nesher Pharmaceuticals LLC
10.2014 - 02.2015
  • Ensures drug products are processed following current Good Manufacturing Practices (cGMP), and master batch records (MBR), and have the safety, identity, quality, and purity purport to possess before release.
  • Responsible for assisting production staff with production problem resolutions and documentation. Determine the impact and monitor environmental program, raw material sampling, and intermediate material specifications, in compliance with applicable regulations 21 CFR Parts 211.
  • Process validation was performed in accordance to ensure the manufacturing process would consistently meet the validation acceptance criteria set in the protocol.
  • Established scientific evidence that the process can consistently deliver a product meeting those attributes relating to product identity, strength, quality, purity, and potency.
  • Monitors work in process for proper use of materials, correct recordings, and possible sources of cross-contamination and reports all deviations to the shift QA Supervisor.

Quality Assurance Specialist

Sigma Aldrich Corp
04.2002 - 08.2013
  • Assist with the management of controlled Quality Assurance documents, production batch (device history) records, change controls, deviations, CAPAs, procedures, validation protocols, raw material, and intermediate material specifications, training documentation, and associated systems in compliance with applicable regulation (e.g. 21 CFR Parts 820, 210 and 211)
  • Developed and implemented a new document repository management system (QUMAS). This process improvement reduced turnaround time from two weeks to two days and reduced overhead by 30% in cost savings.
  • Produced well-written test scripts for Validation automated testing in QUMAS.
  • Written Quality Manual and standard operating procedure (SOP) for Diagnostic, which were regulated by FDA / 21 CFR 820 / ISO 13485 and Biotechnology compliant with ISO 9001.
  • Review of CE Technical File Annually, for IVD products.
  • Lead Auditor of the Internal Quality Audit Program (2008-2012).
  • Schedule conduct and report on internal and external audits, for customers, and suppliers.
  • Developed a new Quality Management System in the SAP module to reduce time for reviewing corrective actions and customer complaints by 50%. The Quality Notifications would track and trend internal and external customer data. Additionally, a long-term audit program for both internal and external audits.

Supervisor / Regulatory Affairs Specialist / Quality Assurance Specialist

Sigma Diagnostic, Inc.
09.1997 - 04.2002
  • Supervised the activities of three direct reports (temporary employees).
  • Review and verify quality and non-quality documents for the Diagnostics Division. Collaborate with other internal departments to address deficiencies identified for regulatory requirements.
  • Conducted research and scientific endeavors with regulatory demands clear and concise communication, utilized negotiation skills as well diplomacy when advising Project management. Also, interpretation of analytical data.
  • Product regulatory submission and recalls. Collaborated with project teams and Plan Study Do Act (PSDA) to decrease development costs and time to market while increasing product exposure in the market.
  • Conducted load tests to determine server operating parameters.
  • Assisted in dossier preparation for our global registrations for In Vitro Diagnostics products.
  • Responsible for adverse event reporting, facility registration and licenses.
  • Device Listing and Product Registration Certification
  • Reviewing and verifying product information, such Labels, Advertising, Labeling, inserts compliance, design and review of IFUs, and package artwork assuring the translations of twelve countries were correct.

Education

Bachelor of Arts - Management Emphasis in Health Relations

Webster University
St Louis, MO
01.2014

Associate of Applied Science - Clinical Laboratory Technology

Forest Park Community College
St. Louis, MO
01.1984

Skills

  • Supervisor Quality Assurance
  • Collaboration skills
  • Understanding of evaluation methodologies
  • Problem-solving skills
  • Sound decision-making abilities
  • Excellent multi-tasker
  • Effective team player
  • ISO 13485 & ISO 9001 knowledge
  • Time management & Organized
  • Personnel training and development
  • Dependable and reliable
  • Detail-oriented
  • Courteous demeanor
  • Cheerful and energetic
  • High-energy attitude
  • Clinical trial oversight
  • Labeling compliance
  • Regulatory strategy
  • Regulatory submissions (Advertising and Promotional)
  • GxP knowledge
  • Regulatory agency applications
  • Audits
  • International regulations
  • Change control
  • Technical writing
  • Product lifecycle management
  • Product information
  • Clinical trials protocols
  • Pharmaceutical industry
  • Biotechnology industry
  • FDA interactions
  • Regulation compliance
  • Excellent communication
  • Multitasking ability
  • Leadership skills
  • Interpersonal skills
  • Regulatory guidelines
  • Continuous improvement
  • Data analysis
  • Documentation management

Accomplishments

  • ISO 9001:2008 Certified
  • Process Improvement
  • Technical writing of new departmental procedures manual. Assessed organizational training needs.
  • Reduced cost of quality (COQ) of CAPAs at Titan Spine by 79% by conducting weekly collaborating team meetings.
  • Transitioned CAPAs from paper-based (manual) process to electronic database aim was to reduce errors by 80%, currently are reduced by 100%.
  • Adherence to CAPA Action Plan aim was to adhere by 80%, has exceeded to 100% adherence, through tracking and trending using Smartsheets as monitoring tool.

Affiliations

  • American Quality Society (ASQ)

Certification

  • ISO 9001, Sigma-Biotechnology - 2012-2014

Timeline

Senior Regulatory Affairs Associate

Amgen (contractor for Ampcus)
06.2022 - Current

Senior Complaint Investigator

Meridian Medical Technologies (A Pfizer Company)
06.2020 - 03.2021

Compliance Investigator

Meridian Medical Technologies (A Pfizer Company)
07.2019 - 05.2020

Regulatory Affairs Associate

Titan Spine LLC
04.2018 - 04.2019

Regulatory Affairs Specialist (Contractor)

Curium Pharmaceutical LLC
02.2017 - 02.2018

Complaint Investigator

Aesculap Inc.
07.2015 - 01.2017

Complaint Investigator (Contractor)

Virbac Corporation
02.2015 - 05.2015

Quality Assurance Coordinator II (Contractor)

Nesher Pharmaceuticals LLC
10.2014 - 02.2015

Quality Assurance Specialist

Sigma Aldrich Corp
04.2002 - 08.2013

Supervisor / Regulatory Affairs Specialist / Quality Assurance Specialist

Sigma Diagnostic, Inc.
09.1997 - 04.2002

Associate of Applied Science - Clinical Laboratory Technology

Forest Park Community College

Bachelor of Arts - Management Emphasis in Health Relations

Webster University

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