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
7
7
years of professional experience
1
1
Certification
Work History
QUALITY ASSURANCE REPRESENTATIVE
CATALENT
08.2022 - Current
- Effectively review/approve GMP documents to ensure quality attributes are met (i.e.: Non-conformances, procedures, protocols, specifications, and change controls).
- Compile and report performance metrics for Batch Review and Release.
- Prepare right first-time reports and keep upper-level management informed of progress as manufacturing review for investigations, deviations and CAPAs.
- Review and approve investigations and associated CAPAs.
- Train incoming employees.
- Review and approve lifecycle documents.
- Assist in self-led inspections and/or provide support during internal/external regulatory inspections.
- Participate in Lean Projects to help improve productivity within local area (Kaizen, Poke Yoke)
- Manage several continuous improvement projects across site with other departments.
- Forward facing with clients.
- Interact effectively with clients to communicate and resolve issues and gain a clear and accurate understanding of each other’s requirements.
- 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.
- Experienced with JDEdwards, LIMS, Trackwise, MES, Excel, SharePoint, Microsoft Word, and Maximo.
- Lead, Mentor and Coach Operation and support personnel on quality matters associated with the Batch/Batch Disposition
- Provides guidance in operational areas to ensure robust Quality Systems and GMP compliance.
- Work in a GMP regulated environment to provide and assist in implementation of quality related activities.
- Performs batch disposition of semi-finished drug product batches for Indianapolis Parenteral products, including commercial and clinical trial materials to ensure high quality medicine (GMP Compliance) is released to market in a timely manner.
- Ensure that compliance to the training program is maintained and updated as needed.
- Work cross functionally with QCL, Equipment team, and Manufacturing to resolve issues while adhering to quality and documentation requirements
- Ability to effectively review and / or redline documents to ensure quality attributes are met (i.e., deviations, procedures, technical studies, validation protocols, change controls, and engineering documents)
- Proactively manage day-to-day business such as interacting with supervisors, quality control, manufacturing specialists, and other cross-functional groups to maintain batch record releases within a timely manner.
MANUFACTURING PRODUCTION ANALYST
CATALENT
10.2021 - 08.2022
- Reviews batch records in a timely manner.
- Participate in the investigation of analytical investigations or deviations, write / review change controls, and investigate deviations as required.
- Train oncoming employees
- Able to read, understand, and execute standard operating procedures according to the Code of Federal Regulations and the site.
- Ability to effectively review and / or redline documents to ensure quality attributes are met (i.e., deviations, procedures, technical studies, validation protocols, change controls, and engineering documents)
- 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
- Participate in self-led inspections and provide support during internal / external regulatory inspections
- Author Events and Deviations in Trackwise
- Train oncoming employees
- Works with JDEdwards, Maximo, MES, LIMS, and Trackwise
- Help develop a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group.
- 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
- Comply with and implement safety standards.
- Assess and triage deviations that occur as well as approve minor deviations
- Approve commissioning qualification / validation documents for computer systems and equipment to ensure compliance with quality standards (VQ's, OQ's, IOQ's, PQ's)
- Participate in the investigation of analytical investigations or deviations, write / review change controls, and investigate deviations as required
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
College Park, MD12.2024
Associate of Applied Science - Biotechnology
IVY TECH COMMUNITY COLLEGE
Bloomington05.2023
Skills
- Technical writing and communication skills
- Strong organizational skills demonstrated through documentation and presentation skills
- Punctual
- Personable with strong oral and written communication
- Works independently
- Highly motivated
- Working knowledge of 21 CFR Parts 11, 210, and 211
- Excellent professional ethics, integrity, and ability to maintain confidential information
- Problem solving and decision-making skills based on client feedback and investigations surrounding the issue
- Risk Assessment
- Conducting Internal Audits
- Continuous Improvement Projects
- Experience in GMP production environments
- Demonstrated attention to detail and ability to maintain quality systems
- Proficient with Microsoft products
- Ability to influence diverse groups
- Strong teamwork and interpersonal skills
Certification
- Biopharmaceutical Manufacturing
- White belt in Six Sigma
Languages
Spanish
Limited Working
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 - Biotechnology
IVY TECH COMMUNITY COLLEGE
- Biopharmaceutical Manufacturing
- White belt in Six Sigma
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