Susie Dyer
Indianapolis,IN
Summary
I'm an intermediate quality documentation specialist with over a decade of experience creating, reviewing, and maintaining documents under a content management system. I meet my goals with effective communication, diligent documentation, and thorough research; I incorporate these while providing exceptional service to a diverse audience. I am looking to apply those skills and knowledge under international standards and federal regulations in a quality-oriented company.
Overview
16
16
years of professional experience
Work History
Quality Assurance Auditor II
Colorcon
03.2025 - 09.2025
- Reviewed batch records for packaging, data, and shipping for accuracy and good documentation practices.
- Audited the campus-wide environmental program for hazardous organisms.
- Scanned documentation and managed the physical and electronic record retention.
Customer Service Associate
JCPenney
10.2023 - 03.2025
- Achieved consistently high levels of customer satisfaction by prioritizing empathy, patience, and effective problem-solving skills, as reported via customer feedback surveys.
- Assisted in training new associates on product knowledge and company policies.
- Managed cash register operations, accurately processing transactions and handling returns.
- Collaborated with team members to maintain store appearance and inventory organization.
Technical Writer
Roche Diagnostics
04.2021 - 04.2022
- Reviewed application sheets and edited method sheets as assigned.
- Collaborated with biomechanical engineers and physicians to establish consensus during reviews.
- Assisted in organization of project management databases.
- CONTRACT
Technical Writer
AllPaid
03.2020 - 05.2020
- Created UX documentation, formerly known as tutorials, for AllPaid.com.
- Anticipated needs per the design team's creative process in order to revise procedures effectively and efficiently.
- CONTRACT
Quality Assurance Lead
Laboratory for Advanced Medicine
03.2018 - 08.2019
- Built a Quality Management System (QMS) for the company's first FDA trial.
- Wrote, implemented, and managed the QMS per applicable federal regulations and international standards.
- Tracked internal auditing, Change Control, CAPA (Corrective and Preventive Action), and incident reports.
- Designed and conducted training for each new QMS process.
- Participated in audit teams for laboratory safety and assisted external lead auditors.
- CONTRACT
Quality Management System Associate
MED Institute, Inc.
12.2009 - 01.2014
- Facilitated changes, improvements, and software development related to the QMS as a technical writer, reviewer, editor, and auditor.
- Developed procedures, SOPs, software development guidelines, policies, guidance, forms, training materials, and other documentation to meet medical device industry standards.
- Interacted with internal customers to research, problem solve, and coordinate QMS activities to ensure the system is functioning properly.
- Tracked status, followed up on progress, and assisted related parties in completing action items regarding the CAPA and Change Control processes, reducing open change requests by 78% and CAPAs by 48%.
- Coordinated meetings, attendees, agendas, and actions associated with the Quality Review Board.
- Prepared, performed, reported, and followed up on internal and external audits of vendors, software, sites, and other facilities and organizations as required.
- Audited and supervised calibration, packaging, and shipping standards.
- Globalized all clinical QMS SOPs (450+ documents), as well as executed an overhaul of all product development procedures (160+ documents).
Education
Bachelor of Arts - English, Creative Writing, Linguistics
PURDUE UNIVERSITY
West Lafayette, IN01.2008
Associate of Occupational Studies - Culinary Arts
AUGUSTE ESCOFFIER School of Culinary Arts
Boulder, CO06-2028
Skills
- Quality assurance processes
- Document and record review
- Quality management systems
- ISO standards
- Corrective and preventive action
- Root-cause analysis
- Procedure modification
- Risk assessment
- Customer service
- Audit process coordination
Timeline
Quality Assurance Auditor II
Colorcon
03.2025 - 09.2025
Customer Service Associate
JCPenney
10.2023 - 03.2025
Technical Writer
Roche Diagnostics
04.2021 - 04.2022
Technical Writer
AllPaid
03.2020 - 05.2020
Quality Assurance Lead
Laboratory for Advanced Medicine
03.2018 - 08.2019
Quality Management System Associate
MED Institute, Inc.
12.2009 - 01.2014
Bachelor of Arts - English, Creative Writing, Linguistics
PURDUE UNIVERSITY
Associate of Occupational Studies - Culinary Arts
AUGUSTE ESCOFFIER School of Culinary Arts
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