I am responsible for managing and supporting quality assurance (QA) activities with a focus on document control, compliance, and training. While at this position I successfully implemented a new company-wide controlled document and training system.

Responsible for managing and supporting quality assurance (QA) activities with a focus on document control, compliance, and training.

Responsible for assisting and supporting quality assurance (QA) activities with a focus on document control and compliance. My duties included the following: *Maintain training curricula for departments as assigned, update changes, and obtain relevant signatures/approvals. Keep version control for all training curricula for record keeping purposes. *Maintain and update changes to controlled documents (CDs) and provide CD revision support, version control, and keep the CD index current. *Manage CD and QA SharePoint site*Review revised/new CDs*Maintain the Corrective and Preventive Action (CAPA) tracker/log and provide support in CAPA documentation routing for signatures and approvals.*Support writing and executing CAPAs as assigned.*Manage secured file room that contains CDs necessary for compliance with regulatory agencies and for audits/inspections.*Support the management of the electronic and hard copy Design History File (DHF).*Support audit preparations *Support inspection preparations and readiness activities.*Administrative duties associated with inspections support to include date stamping documents and reviewing documents for certain criteria and accuracy.*Other duties as assigned.

Conducted a variety of key PV Quality and Compliance activities specifically related to the areas of compliance, document management, and quality control:*Maintained working knowledge and understanding of departmental policies, SOPs, current FDA and international pharmacovigilance regulations and guidance pertaining to drug safety;*Maintained a good understanding of quality system concepts and compliance-related processes and regulations;*Performed Quality and Compliance-related activities requiring meticulous attention to detail and accuracy, good organizational and interpersonal skills, and effective written and verbal communication;*Reviewed adverse event case safety database entries for data quality and helped resolve any trends in data entry errors; *Helped create, review, revise, and quality-control departmental documents; *Performed quality control review of Patient Safety aggregate reports (e.g., DSURs, PSURs);*Support for GVP, GCP, and GMP audits/inspections including but not limited to retrieval, tracking, and management of documentation requests;*Led activities related to document management, including archiving of hardcopy and electronic Patient Safety documents and control of departments' off-site archival activities;*Provided department and company training as needed

*Processed adverse event documents in accordance with department policies and procedures, and FDA or international pharmacovigilance regulations and guidance;*Collected, coordinated, and archived all documents related to adverse event reports received for both clinical studies and marketed products;*Maintained working knowledge of departmental policies, SOPs, FDA and international pharmacovigilance regulations and guidelines pertaining to drug safety;*SOP and Work Instruction coordinator for the Patient Safety Department;*Performed reconciliation between the Patient Safety adverse event database and that of Medical Information, as well as between the Patient Safety and Product Complaint Departments within MedImmune;*Acted as liaison between Patient Safety and Product Complaint Departments to ensure compliant reporting, investigation, and documentation of product lots with associated adverse events;*Participated in monthly site Material Review Board meetings, providing pertinent data for product lot investigations;*Reviewed adverse event case entries for data quality and tracked data quality concerns;*Provided departmental and company training;*Participated in creation, review, revision, and quality control of departmental documents;*Created and maintained archival procedures for department electronic and paper documents, including tracking of all Patient Safety documents archived off-site;*Participated in departmental audit/inspection preparations;*Participated in the creation and execution of Corrective Action Preventative Action (CAPA) plans resulting from audits and inspections;*Provided QC review of aggregate reports.

Responsible for tracking all Severe Adverse Events (SAEs) for HIV vaccine trial ongoing in Thailand. In charge of associated electronic data entry and transmittal of SAE reports to FDA through regulatory affairs office and the Human Subjects Research Review Board (HSRRB). Maintained an intricate filing system for over 2200 SAEs. Corresponded with clinical study site in Thailand as well as site of studies medical monitor in Hawaii to verify information and clarify discrepancies, ensuring the accuracy of all volunteer information. Interacted with a Data Coordinating and Analysis Center to provide current SAE reports, follow-ups on reports, and corrections to incorrect data. Assisted the Principal Investigator by developing an Excel log to keep track of all Expedited Adverse Event reports for various other studies both past and present, that could easily be used to find information on any patient and track documentation. Tracked and logged deviations to ongoing study in Thailand so they could be sent to HSRRB. Attended Good Clinical Practice training at Fort Detrick as well as a two-day workshop on monitoring clinical studies.

Assisted the laboratory director in support of clinical trials, diagnostic effects, and the MHRP's goals and objectives by overseeing day-to-day operations of the specimen processing lab (SPL). Participated in clinical protocol development meetings with MHRP clinical sites and the Data Coordinating and Analysis Center to ensure adherence to clinical protocol requirements and to provide necessary support and guidance for proper handling of specimens. Participated in the development of new Standard Operating Procedures and assisted the SPL director during internal and external laboratory inspections and audits. Developed and reviewed quality assurance/quality control procedures as well as continued to oversee new employee training and continued tracking of supply inventory and equipment performance.

Assisted the laboratory director and manager in supervising the daily operations of a laboratory performing specimen processing in support of clinical trials and diagnostic efforts of the MHRP. Responsible for determining the workload of laboratory personnel, providing assistance to clinical trial coordinators, and the training of visitors and new laboratory personnel.

Supported the U.S. Military HIV Research Program (MHRP). Performed blood processing for the laboratory using cellular biology methods such as ficoll density centrifugation to recover lymphocytes and plasma from whole blood using sterile technique. Responsible for preparation of laboratory buffers and reagents, maintaining specimen freezer inventories, ordering and stocking laboratory supplies, ensuring up-to-date laboratory records and a safe work area with appropriate disposal of infectious waste.