Catiana Augusme

Work History

Founder

PromptCare Logistix

05.2025 - Current

Developed strong partnerships with other businesses to allow for collaboration and more significant opportunities for growth.
Established a successful business by identifying market needs and developing innovative solutions.
Delivered exceptional customer service by addressing client concerns promptly and effectively resolving issues.
Led the strategic planning process to define business goals and ensure alignment across all departments.

Quality Assurance Specialist II

Precision for Medicine

Frederick, MD

06.2024 - Current

Company Overview: Global CRO
Provide hands-on support from a regulated systems perspective in a GxP/ GMP laboratory services environment.
Assist in maintaining established company-wide GxP quality systems, actively managing assigned activities (including logging and tracking of events and outcomes), and working with end-users on thorough documentation of quality system events (to include closure or resolution in a timely manner):
Non-Conformances
Customer Complaints
Planned Deviations
Change Management
Corrective and Preventive Action (CAPA)
Supplier Quality Management
Audit Programs
Employee Training
Document & Record Control
Maintain monthly metrics and reporting tools for all aspects of quality systems, to include presentation of metric performance to management representatives
Independently conduct internal audits, supplier evaluations, and desk audits working with end users to identify performance issues and risk mitigation strategies assist in preparing subject matter experts for audit interviews
Actively participate in daily operations as an on-the-floor QA representative and conduct process observations to written SOPs/accuracy of batch record/test method execution, and mentor personnel in industry best practices
Serve as quality lead for validation activities, including review and approve validation protocols, reports, and final package documentation
Assist in the QA review and acceptance of customer specifications to conform to contractual requirements
Generate and maintain label formats for manufactured and resale products
Inspect and approve all product labels generated by Operations
Provide support to other departments regarding requests, release status, regulatory requirements and other tasks as requested
Develop and distribute controlled quality system documentation
Work with functional groups to develop correct documentation required to document evidence for the manufacturing/processing, testing and release of products and services
Develop and maintain databases/spreadsheets for document control
Perform area walkthroughs and audits for compliance to written expectations
Collaborate with Project Management to plan upcoming quality deliverables and enforce compliance accountability
Inspect and release incoming raw material, critical components, packaging and labeling in accordance with individual specifications and standard operating procedures
Investigate client Complaints and Non-Conformance Issue by addressing customer complaints and non-conformance issues by identifying root causes and implementing corrective actions.
Report Quality Metrics by Preparing and presenting reports on quality metrics and performance to management, highlighting areas for improvement.
Remain informed on industry trends by continuously studying current and new industry trends and methods to enhance quality testing measures.
Train staff personnel by providing training to team members on quality assurance practices, regulatory requirements, and standard operating procedures.
Global CRO

Quality Specialist I

Parexel

Maryland

02.2023 - 06.2024

Company Overview: Global CRO
Provide Quality support in a GCP/ GVP/ GLP environment.
Collaborate with study team members such as Project leaders, Project Directors, Clinical operation leads and Senior CRAs to manage Minor, major and Critical Quality issues reported on Trackwise.
Reported Quality Metrics by Preparing and presenting reports on quality metrics and performance to management, highlighting areas for improvement.
Partner with the clinical trial operational delivery teams focusing on first-time quality, robust risk and issue management, and maintaining an inspection-ready state
Provide quality oversight support to project team management throughout assigned projects.
Conduct remote quality evaluations to proactively identify and address potential quality risks or issues, quality consultation, CAPA support, audit and inspection support. Communicate results to the project team (PM, PL, FLs). As assigned collecting, reviewing and reporting of project quality metrics.
Perform, report, and coordinate the quality evaluations for assigned projects
Provide quality consultation support to project teams.
Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Manage all quality issues reported.
Manage the progress of all assigned studies by reviewing risk trends
Manage Quality Issues (QIs) and support QI management including classification, root cause analysis, consultation on appropriateness of corrective and preventive actions, as assigned.
Support Project Quality & Risk Lead (PQRL) and Operations with audits and inspections, as assigned.
Identify and evaluate potential risks and quality issues in collaboration with PQRL and determine appropriate mitigation measures.
Support project teams with internal audits, sponsor audits, TMF audits, for cause audits and managing audit findings.
Identify process improvement and conduct risk signal evaluations for assigned studies.
Work closely with Operational management and with Line Manager to ensure continuous process improvement, as assigned.
Successfully aided in the implementation of internal SOPs.
Completed data analysis to observe trends of product.
Global CRO

Quality Assurance Specialist I

Velocity Clinical Research

Rockville, MD

12.2020 - 02.2023

Company Overview: Research Site (Company previously known as Meridian Clinical Research)
Provide Quality support in a GCP/ GMP/GVP/ GLP environment.
Assisted with qualification, initiation, monitoring, and closeout visits at both research sites in compliance with the approved protocol.
Created Note-to-Files as needed and assisted project teams in developing and implementing corrective and preventive action plans (CAPAs)
Provided consultation in Sponsor and FDA Audits
Conduct internal site audits/regulatory inspections
Trained all medical site staff including coordinators and clinical research physicians.
Developed and Implemented quality control Systems by designing and maintaining quality management systems to ensure continuous improvement and compliance with industry standards.
Conducted internal audits and inspections by performing regular internal and external audits to ensure adherence to quality standards and regulatory requirements.
Tested products and services by conducting tests to identify areas for improvement and ensure products or services meet established quality standards.
Documented and analyzed results by maintaining detailed records of testing results and analyze data to identify trends and areas for improvement.
Collaborated with various project Teams such as PI, SUB-I and CRAs to ensure all study protocols are implemented correctly at the site.
Investigated client Complaints and Non-Conformance Issue by addressing customer complaints and non-conformance issues by identifying root causes and implementing corrective actions.
Reported Quality Metrics by Preparing and presenting reports on quality metrics and performance to management, highlighting areas for improvement.
Remained informed on industry trends by continuously studying current and new industry trends and methods to enhance quality testing measures.
Trained staff personnel by providing training to team members on quality assurance practices, regulatory requirements, and standard operating procedures.
Research Site (Company previously known as Meridian Clinical Research)

Summary

Work History

Founder

Quality Assurance Specialist II

Quality Specialist I

Quality Assurance Specialist I

Education

Bachelor's Degree - Social Science

Master's Degree - Public Health

Skills

Personal Information

Additional Qualifications

Therapeutic Areas Specialties

Timeline

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