ASHLEY SMITH
Heltonville,Indiana
Summary
Ambitious Quality Analyst with track record of dependability and leadership. Knowledgeable in QA methodology with proven history of reducing errors to increase quality. Dedicated to analyzing and resolving defects.
Overview
6
6
years of professional experience
Work History
QUALITY ASSURANCE REPRESENTATIVE
CATALENT
08.2022 - Current
- Critically review various documentation types to ensure completeness, accuracy, and compliance.
- Compile and report performance metrics for Batch Review and Release.
- Prepare right the first-time reports and keep upper-level management informed of progress as manufacturing review for investigations, deviations and CAPAs.
- Train incoming employees.
- SUQ and Disposition records.
- Investigate and author Deviations, parent actions, and child actions.
- Manage and complete continuous improvement projects.
- Forward facing with clients.
- Aided in FDA related projects and investigations.
- Able to read, understand, and execute standard operating procedures according to the Code of Federal Regulations and the site.
- Revise and justify revisions on standard operating procedures.
- Provide solutions and suggestions to issues.
- Experienced with JDEdwards, LIMS, Trackwise, MES, Excel, SharePoint, Microsoft Word, and Maximo.
- Provide expertise and guidance in interpreting policies, regulatory guidelines, and regulations to ensure compliance.
- Work in a GMP regulated environment to provide and assist in implementation of quality related activities.
- Coordinate with other departments to facilitate uniform quality standards for the site.
- Ensure that compliance to the training program is maintained and updated as needed.
MANUFACTURING PRODUCTION ANALYST
CATALENT
10.2021 - 08.2022
- Reviews batch records in a timely manner.
- Investigate and author deviations, parent actions, and child actions.
- Train oncoming employees
- Able to read, understand, and execute standard operating procedures according to the Code of Federal Regulations and the site.
- Revise standard operating procedures.
- Identified trends and patterns in large datasets, leading to actionable insights for site growth.
- Cultivated relationships with industry leaders and within company to share tips and information.
- Generated reports detailing findings and recommendations.
- Maintained database systems to track and analyze operational data.
- Provide solutions and suggestions to issues encountered within the batch record.
- Collaborated with cross-functional teams to identify opportunities for process improvement and increased efficiency.
- Recommended process improvements to continually identify, analyze and fix constraints and challenges.
QUALITY ASSURANCE TECHNICIAN
CATALENT
09.2020 - 10.2021
- Provide oversight of systems to ensure compliance with internal policies, procedures, and guidelines.
- Maintain a 100% compliance for all training within ComplianceWire
- Perform room audits
- Author Events and Deviations in Trackwise
- Train new employees
- Lead Weekend AM triage for Events and Deviations
- Level Deviations using RPNs
- Works with JDEdwards, Maximo, MES, LIMS, and Trackwise
- Coordinate and liaise with other departments to facilitate uniform quality standards for the site
- Provide QA support and be a primary point of contact for quality systems and other operational systems
- Provide expertise and guidance in interpreting policies, regulatory guidelines, and regulations to ensure compliance
- Work in a GMP regulated environment to provide and assist in implementation of quality related activities.
- Conducted root cause analyses for identified defects, implementing preventive measures to minimize recurrence rates.
- Collaborated with cross-functional teams to develop comprehensive quality control strategies, ensuring optimal product performance.
- Ensure that compliance to the training program is maintained and updated as needed
DNP QC INSPECTOR
COOK MEDICAL
11.2017 - 09.2020
- Operate in GMP Facility with required gowning procedures.
- Utilized visual inspection techniques as well as performing detailed measurements with hand-held tools and devices.
- Maintained a strong working knowledge of industry regulations and standards, ensuring that all inspections were conducted in accordance with applicable requirements.
- Provided timely feedback to production staff regarding any identified deviations from established specifications or procedures, promoting a proactive approach to maintaining quality standards.
- Conducted final inspections on completed products prior to shipment, ensuring customer satisfaction with delivered goods.
- Inspected products, components, and materials for defects and compliance with tolerance standards.
- Checked color, shape, texture and grade of products and materials against established templates, charts, and samples.
Education
BIOTECHNOLOGY -
UNIVERSITY OF MARYLAND GLOBAL CAMPUS
12.2024
Associate of Applied Science -
IVY TECH COMMUNITY COLLEGE
05.2023
Skills
- Technical knowledge
- Quality Assurance
- Organized
- Personable with strong communication skills
- Works independently
- Highly motivated
- Working knowledge of 21 CFR Parts 11, 210, and 211
- Excellent professional ethics, integrity, and ability to maintain confidential information
- Risk Assessment
- Audit processes
- Continuous Improvement
- Project Management
Timeline
QUALITY ASSURANCE REPRESENTATIVE
CATALENT
08.2022 - Current
MANUFACTURING PRODUCTION ANALYST
CATALENT
10.2021 - 08.2022
QUALITY ASSURANCE TECHNICIAN
CATALENT
09.2020 - 10.2021
DNP QC INSPECTOR
COOK MEDICAL
11.2017 - 09.2020
BIOTECHNOLOGY -
UNIVERSITY OF MARYLAND GLOBAL CAMPUS
Associate of Applied Science -
IVY TECH COMMUNITY COLLEGE
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