Catiana Augusme, MPH

-Executes assigned actions related to the corporate Quality Plan.
• Provides guidance to eQMS modules users.
• Reviews and approves document change requests and CAPAs submitted by internal stakeholders.
• Liaises with internal stakeholders to facilitate the development/revision and review of QMS documents (SOPs, Work
Instructions, Associated Documents), Root Cause Analysis/CAPAs and training materials as required.
• Leads improvement initiatives for quality processes against corporate standards and regulatory requirements.
• Supports audits (internal, site, vendor) and associated Corrective Action and Preventive Actions (CAPA’s).
• Provides guidance, as required, to internal stakeholders related to the interpretation of GCP and regulatory requirements.
Conduct Regulatory, Ethical Conduct and Audit Monitoring (10-15%)
• Remains current on and communicates changes to relevant regulatory requirements and industry standards.
• Assists in the identification of process changes to QMS documents and/or training requirements to meet regulations,
standards, and sponsor expectations.
• Supports Sponsor and regulatory inspections or audit activities.
Provide Quality Assurance Training (20-25%)
• Identifies, creates, adapts, and delivers quality assurance orientation as well as department, project team and clinical site
quality assurance training programs.
• Develops and maintains Training Matrix and Training Plans for Alimentiv staff.
• Liaises with Human Resources to communicate training assignments.

Translational Research | Global CRO
-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
*Planned Deviations
*Change Management
*Corrective and Preventive Action (CAPA)
*Root Cause Analysis
*Supplier Quality Management
*Audit Programs
*Employee Training
*Document & Record Control
-SOP technical writing
-validation report writing
-Verification review / change management
-Participating on the Material Review Board
-Assist in scheduling, performing, and reporting internal audits, as well as supplier audits, and related activities
-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,
evaluations, and desk audits working with end users to identify performance issues and risk mitigation strategies
-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
-Collaborating with Project Management to plan upcoming quality deliverables and enforce compliance accountability

Clinical research | Global CRO
• 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.
• Participate in relevant project team training.
• Provide support with investigation of Quality Issues (QIs) and support of 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.
• Identify process improvement opportunities.
• Work closely with Operational management and with Line Manager to ensure continuous process improvement, as assigned.
• Remain informed about developments in relevant regulations and guidelines.
• Establish and maintain good and efficient communication lines within Project Quality & Risk Management (PQRM), Operations staff and other Quality and functional departments, as appropriate.
• Assist in the maintenance of the relevant website, Parexel Connect page and PMED filing areas, as needed.
• Support developing training materials and/or deliver training related to Project Quality & Risk Management (PQRM) activities, as assigned.Clinical research | Global CRO • 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. • Participate in relevant project team training. • Provide support with investigation of Quality Issues (QIs) and support of 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. • Identify process improvement opportunities. • Work closely with Operational management and with Line Manager to ensure continuous process improvement, as assigned. • Remain informed about developments in relevant regulations and guidelines. • Establish and maintain good and efficient communication lines within Project Quality & Risk Management (PQRM), Operations staff and other Quality and functional departments, as appropriate. • Assist in the maintenance of the relevant website, Parexel Connect page and PMED filing areas, as needed. • Support developing training materials and/or deliver training related to Project Quality & Risk Management (PQRM) activities, as assigned.

(Previously known as meridian clinical research)
Research site | Several therapeutic indications
•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
•QA/ QC Management
• in vitro diagnostics
•Trained all medical site staff including coordinators and clinical research physicians.
•Ensured all good documentation practices are being adhered to and identifying protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements.
•Monitored activities with a risk-based monitoring approach (including centralized data review) through our integrated Clinical Trial Management System to identify site deviations/deficiencies and corrective/preventive actions to bring a site back into compliance.
•Identified site trends, implemented SOP training and training to site coordinators
•Assisted in accuracy in data reporting in accordance with the protocol; such as review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol
•Verify required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records.
•Participated in site study startup/ Close out process including IRB submissions and related communications.