Ryen Smith
Madison,WI
Summary
I am a Quality Assurance associate with over 3 years of experience in the pharmaceutical manufacturing field as well cytotechnology. Experience in validating brand new systems to the company including SLIM and LIMS. Responsible for maintaining releases and reviews of products that meet cGMP requirements. Possess strong skills in process improvement, product testing, and regulatory compliance. Demonstrated history of improving efficiency while maintaining the highest quality standards. Proven ability to lead teams and deliver projects on time and within budget.
Overview
4
4
years of professional experience
Work History
Quality Assurance Associate
Wicell Research Institute
Madison, WI
01.2023 - 01.2025
- Performed Batch Record Reviews in accordance to cGMP 211 Guidelines
- Performed release of client 211 reports such as STR, Karyotype, FISH.
- Executed assay review of raw materials in the laboratory such as Microarray, Karyotype, STR, FISH, etc.
- Experience with initiating and executing CAPAs, Customer complaints, Contamination Reports, Deviations.
- Lead reviewer for external audits related to WiCell
- Performed internal audits for WiCell for 2 years.
- Reviewed laboratory labels, raw materials, lab notebooks, and logbooks in accordance to cGMP guidelines.
- Filed and Maintained controlled documents
- Created new fields inside the LIMS system to better assist Quality Control needs.
- Participated in cross-functional teams focused on developing solutions for identified quality issues.
- Created training materials for employees on Quality Assurance topics such as inspection techniques and process validation protocols.
- Assisted in the development of new methods for improving existing processes related to product quality control.
- Reorganized and revised standard operating procedures to streamline processes and improve communication and collaboration.
- Prepared and presented detailed reports on quality metrics, trends, and improvement initiatives to management.
Quality Assurance Technical Associate
Precision Dose Inc
South Beloit, United States
09.2021 - 12.2022
- Review archival od documents used to support good manufacturing practice manufacture of nal product
- Support internal and external audits as assigned
- Perform review and release of raw materials, intermediate products and nal products
- Perform review of and approval of environmental monitoring records
- Assist with writing, revising, and approving standard operating procedures
- Perform/review investigations, IRs, and TCOs
- Conduct GMP training for peers of other departments
- Conduct validation of new systems such as SLIM
- Conduct/review the release of drug related products to the market
- Conduct/review customer complaints in accordance to the company
Pharmacy Technician
Hartig Drug Company
Platteville, WI
11.2020 - 09.2021
- Received and verified daily incoming drug inventories, reported discrepancies and logged items into inventory system.
- Retrieved medication from shelves based on physician orders and delivered them to pharmacists for review.
- Operated cash registers to accept payments from customers.
- Received written prescription or refill requests, verifying information for completeness and accuracy.
- Prepared compound medications under the supervision of a licensed pharmacist.
- Maintained daily inventory of pharmaceuticals and ensured proper storage conditions.
- Monitored inventory levels of commonly used drugs and placed orders when necessary.
- Communicated effectively with doctors and insurance agencies to resolve prescription cost discrepancies.
- Provided customer service to patients by answering questions about medications and health-related topics.
Education
Bachelor's Degree - Biology
UNIVERSITY OF WISCONSIN
Platteville, United States05.2020
Degree - Biology
ROCK VALLEY COLLEGE
Rockford, United States05.2018
Skills
- Reliable
- Critical Thinking
- Professional Attitude
- Detail-Oriented
- Planning
- Prioritization
- Stress Management
- Hardworking
- Decision-making
- Quality improvements
- Risk management
- Team leadership
- Verbal and written communication
- Quality management systems
Websites
Timeline
Quality Assurance Associate
Wicell Research Institute
01.2023 - 01.2025
Quality Assurance Technical Associate
Precision Dose Inc
09.2021 - 12.2022
Pharmacy Technician
Hartig Drug Company
11.2020 - 09.2021
Bachelor's Degree - Biology
UNIVERSITY OF WISCONSIN
Degree - Biology
ROCK VALLEY COLLEGE
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