Joana Samad Email & Phone Number

Alachua, Fl, Us

Fargo, North Dakota, United States

North Carolina, United States

We are dedicated to improving the daily lives of patients, sites, and sponsors.YPrime’s eCOA solutions are designed to minimize the burdens and barriers of participating in clinical trials. We deliver cleaner data, enhance clinical trial efficiency, increase site satisfaction, and improve patient compliance.

Remote

Gainesville, Florida, United States

I can provides cross-functional leadership and project management for your organization in the field of Quality projects, programs and initiatives; such as those associated to Quality Management Plans (QMPs). A key role in ensuring development and implementation of regulatory compliance programs, continuous improvement, and effectiveness of the QMS programs.

Alachua, Florida

• Actively participated as a member and managed the Internal Auditor Team responsible for auditing company regulations as they pertain to outside agency regulations (FDA, AATB, etc.) and company policies.• Assist QA/RA personnel in preparing regulatory documentation for various submissions (i.e., 510ks, etc.).• Train employees, interns, and consultants on new and revised Quality documents, Quality Systems, and current Good Tissue Practices.• Work with all employees, to include off-site employees, to ensure all other training requirements are completed (i.e., Blood-borne Pathogen, ER training, etc.). • Supervise and participate in a multi-document controlled filings system for national and international clients, often coordinating a team of several employees to ensure timely and accurate filings (Company re-certifications and/or license renewals).• Maintain paper and electronic Quality Records system, including filing Operating Procedures, Forms, Policies, etc. Maintain the Master Training, NCR, Equipment, CAPA, CAR, etc. Logs.• Assist with activities involving domestic and international regulatory agencies, and the American Association of Tissue Banks.• Actively participate as an External Auditor of company’s Recovery Agencies, Suppliers and Support Companies for compliance to company policies, outside regulations and governing agency regulations.• Responsible for the management of program operations as they related to the business aspects of contract sales representative, which include contract administration, procurement, finance, accounting and formal company/customer contract interfaces. Responsible for all interpretations of the Proposal, negotiations, and contract amendments. Managed routine proposals and contracts.RESULTS • Created entire Quality documents (Controlled/uncontrolled) filing system that reduced inaccuracies and misfiling. • Instrumental in the Company’s AATB certification after being with company only 4 months

Gainesville, Florida, United States

Supervise and participate in a multi-document controlled filings system for national and international clients, often coordinating a team of several employees to ensure timely and accurate filings (Company re-certifications and/or license renewals).• Maintain paper and electronic Quality Records system, including filing Operating Procedures, Forms, Policies, etc. Maintain the Master Training, NCR, Equipment, CAPA, CAR, etc. Logs.• Assist with activities involving domestic and international regulatory agencies.• Responsible for the management of program operations as they related to the business aspects of contract sales representative, which include contract administration, procurement, finance, accounting and formal company/customer contract interfaces. Responsible for all interpretations of the Proposal, negotiations, and contract amendments. Managed routine proposals and contracts.

Various

Served 10 years in the U.S. Army as a Military Police (95B, now 31B in the Army). Protected lives and property on various Army installations by enforcing military laws and regulations, controlling traffic, preventing crime, responding to all emergencies, and supporting numerous Army field Divisions (1st Armored Division and 3d Armored Division) to name a couple. Served two tours in Germany and three tours in the United States. Lead various size squads and platoons throughout my 10 year career.

Quality Systems & Improvement Management

As, Criminal Justice