Amanda Vanterpool

• Led stakeholders workshops to access pain-points in process execution, resource burden and system limitations at client and proposed roadmap for business process optimization and implementation of new electronic QMS.
• Designed and developed investigation training material and supporting materials (e.g. job aids, root cause analysis templates, etc.) based on historical review of investigations, client's procedures and policies, and regulatory standards to drive consistency and improved robustness of investigations.
• Led initiative at client facility to re-access equipment and facility alerts based on risk level and implemented consistent responses to equipment out-of-specification/ out-of-tolerance, including review of existing equipment/ facilities maintenance for potential gaps.
• Led effort to transition manufacturing oversight to client after 1 year of outsourcing. Drove adoption of new ways of working for manufacturing oversight organizationally from bottom up, with procedural changes, training program development, defined RACI and structured incentives program.
• Assigned tasks to lower-level personnel based on qualifications and skills set.
• Improved customer satisfaction by quickly and effectively addressing inquiries and complaints.
• Promptly mediated disputes between associates to promote better collaboration and avoid work disruption.

• Manage Corrective and Preventative Action (CAPA) process - improved CAPA program from 55% timeline compliance to 100% compliance and 75% effectivity to 100% effectivity in 12-months through root cause analysis training and enforcement of timeliness policy.
• Tracked corrective action reports and confirmed closure of corrective action requests to demonstrate adherence to quality standards
• Manage and implement process improvement projects for Quality Management System in response to Food and Drug Administration (FDA)/ International Organization for Standardization (ISO) findings, internal audit findings and overall leaning and error proofing of processes.
• Serve on backroom team for FDA, ISO and internal audits.
• Act as Subject Matter Expert for CAPA process and Document Control Process in FDA, ISO and internal audits.
• Maintained quality system documentation and updated specific documents to reflect new audit or test results.
• Create and update Policies, Standard Operating Procedures (SOPs) and Work Instructions for Quality Management system (Deviations, CAPA, Document Control, Quality Planning, Training, Internal Audits) to comply with 21CFR Part 11, 21CFR Part 210/ 211, 21CFR Part 820 and ISO 13485.
• Conduct training for current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), Data Integrity and Root Cause Analysis.
• Perform System Administrator role of electronic Quality Management Software - eQMS (QCBD and MasterControl) - implemented eQMS (QCBD) from manual paper system, assisted in migration to MasterControl.
• Configure and develop/ execute UAT for eQMS modules including CAPA, Complaints, Supplier Corrective Action Reports (SCARs), Laboratory Investigations, Equipment Management.
• Conduct data integrity audits in Analytical Laboratory.
• Print and Review labels for commercial product.
• Create and update label artwork designs in accordance with Marketing team input and FDA regulations.
• Investigate non-conformances related to Quality Management System.
• Evaluated suitability of business and technical processes and procedures and recommended improvements to comply with updated operations guidelines.

Full Time (Mar 2016 - Oct 2016); Part Time (Oct 2016 - Jul 2018)

• Supported Manufacturing department; tested products from manufacturing line as well as various experimental products.
• Conducted investigations using protocols following cGMP - ISO and FDA guidelines, and recorded results following GDP.
• Trained new staff in instrument maintenance, assay protocols, documentation protocols and bio-safety procedures.

• Promoted from Molecular Biologist.
• Supervised staff and acted as manager in absence of Lead Biological Scientist.
• Trained and ensured competency of staff; ensured compliance to SOPs.
• Wrote comprehensive reports on test findings.
• Acted as Quality Assurance Lead.
  
• Completed root cause investigations and implemented CAPAs for audit findings.
• Completed same roles and responsibilities as Molecular Biologist.

• Performed diagnostic molecular testing to rapidly identify and characterize potential pathogenic bacterial and viral threat agents.
• Prepared written and oral reports, answered questions, troubleshot and made recommendations to supervisor for inclusion in comprehensive reports on test findings.
• Acted as Quality Assurance Lead and reduced number of audit non-conformance by 50% over 12-month period.
  
• Created and updated SOPs and other documents (Forms and Job aids) to comply with company's Quality Assurance Plan and Policies.
• Maintained up-to-date documents provided by Program office (archived obsolete documents and replaced with current versions).
• Maintained Safety Data Sheets (SDS), Certificate of Analysis (CoA) and packaging documents for all consumables and reagents received.
• Reviewed daily data sheets and forms for accuracy and completeness.
• Performed internal audits on documentation, procedure and equipment maintenance.
• Performed root cause analysis, wrote corrective action reports and implemented improvements and controls to eliminate and/ or mitigate issues or potential issues.
  
• Scheduled and assigned staff members various tasks to allow for timely completion of projects and laboratory tasks.

• Performed research on human blood cells from chronic HBV+ patients and characterized blood cells present in liver transplant perfusions.
• Developed, optimized and conducted experimental protocols as required in BSL-2 laboratory independently.
• Recorded protocols used and results obtained, analyzed data and prepared weekly presentation of findings.
• Created database of patient demographics and health information according to HIPAA.
• Monitored and maintained documentation of handling, storage and disposal of hazardous substances (SDS and CoA).
• Managed lab orders and grant fund allocation.
• Supervised and trained undergraduate and graduate students in lab safety and experimental protocols.