Operations Support - responsible for managing systems and administrative processes. Focused on internal procedures, integrity of external databases, directories and accreditation rules. Responds to internal and external customer queries related to status of audit scheduling, audit report, certification, invoicing, and other non technical questions. Generally supports all other Food Safety teams with client management and audit delivery.

•Manage certification projects for assigned clients, helping them to meet standards for public health and safety. Promptly process all records and documentation, determine appropriate testing and reviews required for certification. Compile necessary documentation to support certification. Facilitate certification projects by interfacing with other departments (auditing, toxicology, chemistry) to help ensure timely testing and evaluation of products. Resolve issues of non-compliance as… Show more •Manage certification projects for assigned clients, helping them to meet standards for public health and safety. Promptly process all records and documentation, determine appropriate testing and reviews required for certification. Compile necessary documentation to support certification. Facilitate certification projects by interfacing with other departments (auditing, toxicology, chemistry) to help ensure timely testing and evaluation of products. Resolve issues of non-compliance as appropriate. Promote risk management solutions to all clients. Show less

• Primary point of contact for 50 State licensing and permit services for bottled water clients. Compile relevant client information utilizing electronic document management systems to submit initial state applications and renewals. • Review required documents against FDA and state regulations. Work closely with clients and state representatives so that applications are completed accurately and meet regulatory requirements.

Manage certification projects for assigned clients, helping them to meet standards for public health and safety. Promptly process all records and documentation, determine appropriate testing and reviews required for certification. Compile necessary documentation to support certification. Facilitate certification projects by interfacing with other departments (auditing, toxicology, chemistry) to help ensure timely testing and evaluation of products. Resolve issues of non-compliance as… Show more Manage certification projects for assigned clients, helping them to meet standards for public health and safety. Promptly process all records and documentation, determine appropriate testing and reviews required for certification. Compile necessary documentation to support certification. Facilitate certification projects by interfacing with other departments (auditing, toxicology, chemistry) to help ensure timely testing and evaluation of products. Resolve issues of non-compliance as appropriate. Promote risk management solutions to all clients. Show less

Coordinate, analyze and track the fulfillment of complex information requests to support discovery, clinical research, regulatory, audit and litigation activities. Process and maintain pre-clinical, clinical and regulatory records.

Senior Associate – Clinical Study and Data Management – 2003 – 2004 Protocol contact supporting operational activities and milestones associated with managing complex clinical trial data with an emphasis on data management activities throughout study start-up, study conduct and study close-out.• Identified data and documentation issues and analyzed trends that could potentially impact Outsourcing/CRO transition and work to develop resolutions.• Identified potential study… Show more Senior Associate – Clinical Study and Data Management – 2003 – 2004 Protocol contact supporting operational activities and milestones associated with managing complex clinical trial data with an emphasis on data management activities throughout study start-up, study conduct and study close-out.• Identified data and documentation issues and analyzed trends that could potentially impact Outsourcing/CRO transition and work to develop resolutions.• Identified potential study problems or data issues not covered in the Data Management Plan.• Monitored data collected for accuracy and processed data discrepancies, issued and resolved queries appropriately and within service level agreements. • Data entry and management including developing processes to ensure timeliness and accuracy of data capture and reporting. This includes data entry of confidential clinical information Show less

Data Coordinator - Clinical Sciences – 1998 – 2003 Managed complex clinical trial data for Phase 4 clinical trials in accordance with SOPs, regulatory guidelines and project requirements in support of multiple drug projects.• Reviewed and processed data discrepancies, issued and resolved queries. • Recorded changes on CRFs (case report forms) according to SOPs, the Data Management Plan and departmental guidelines. • Developed high quality database applications while… Show more Data Coordinator - Clinical Sciences – 1998 – 2003 Managed complex clinical trial data for Phase 4 clinical trials in accordance with SOPs, regulatory guidelines and project requirements in support of multiple drug projects.• Reviewed and processed data discrepancies, issued and resolved queries. • Recorded changes on CRFs (case report forms) according to SOPs, the Data Management Plan and departmental guidelines. • Developed high quality database applications while participating in the discovery and development of new technologies for process improvement. Released an average of 8 clinical study databases a year while meeting all quality standards and development operations timelines.• Data entry and management including developing processes to ensure timeliness and accuracy of data capture and reporting. This includes data entry of confidential clinical information• Project Plan Manager for multiple Study Teams within Clinical Sciences. Worked with team members individually and during study team meetings to forecast and plan project tasks leading to study completion, timely database release and research report completion. Maintained project plans including requesting, updating and archiving project plans as appropriate. Reviewed, maintained and communicated the weekly Missed Deadlines report. Show less