Executive

Summary

Experienced in leading and collaborating with diverse teams, marketing, conflict resolution and data analytics. Proven talent for analyzing problems, developing and simplifying procedures, and finding innovative solutions within organizations. Skilled in directing complex, mission-driven projects from concept to fully operational status. Successful at designing and implementing strategies and governance models to ensure organizational alignment between ongoing action and stated mission. Master of Public Administration candidate specializing in program evaluation, analysis and management. Professional experience and academic training in strategic communications, outreach and common activities.

Education

Barry University

Master in Public Administration, July 2014 Miami Shores, Florida

Concentration in Leadership

Coursework: Research Methodologies, leadership, negotiation, leadership strategies.

Barry University Miami Shores, Florida

Master of Arts, July 2012

Major: Administration Miami Shores, Florida

Bachelor of Science, May 2010

Major: Administration; Minor: Human Resources Administration

Professional Experiences:

MERCK SHARP & DOHME Miami Lakes, Florida

April 2011-

Present

July 2007-Dec 2010

Quality Assurance Auditor

Establish and maintain regulatory information systems. Support new market requirements by writing Products Specification and Standard Operation Procedures based on current procedures and site needs.

Provide update on regulatory requirement changes, which affect individual product specification or quality systems.

Provide support for the Regulatory Department to ensure efficient and compliant business processes and environment.

Act as point of contact for requesting any required data and additional information as needed. Write and revise documents and procedures relevant to the auditing function. Investigate impact of changing regulations on submission strategies.

Ensure that all regulatory-related policies and procedures are current in accordance with applicable regulations and standards.

Azopharma Drug Development Services, Inc. Miramar, Florida

Quality Assurance Documentation Auditor

Entered data pertinent to investigations, inspections, and incidents into the manufacturing database Performance and Results Information System.

Increased quality impact to product integrity by continuous awareness and knowledge based training as well as identification and problem solving by enhancement of Standard Operating Procedures, SOP’s. Promoted safety and security awareness

Identified Risks, Potential Risks, and Unknown Risks from Customer Technical Complaints

Wrote and Reviewed Standard Operating Procedures for cGMP. Ensured employees adhere to the company’s regulations, policies and standard operational procedures.

Increased quality impact to product integrity by continuous awareness and knowledge based training as well as identification and problem solving by enhancement of Standard Operating Procedures, SOP’s.

Ensured appropriate escalation of significant complaints to management. Contacted stakeholders if necessary to due potential medical impact of a Pharmaceutical Technical Complaints. Conducted internal and external investigations.

Collected and entered data and evidence relevant to investigations and inspections.

Ensured safe transport of hazardous materials.

Conducted regulatory inspections/investigations and supports investigations related to alleged or suspected security violations. Conducted emergency drills and protocols due to manufacturing policy.

Assisted with Pharmaceutical Technical Complaints reconciliation between the different sources.

Verified that all quality assurance activities are performed in accordance with specifications. Increased quality impact to product integrity by continuous awareness and knowledge based training as well as identified problem solving related to Standard Operating Procedures.

Monitored each operation to assure they are compliance with document instructions such as Sop’s, GMP, OSHA, FDA, EU and DEA and in compliance within the company policies and global regulation.

Reviewed and analyzing assessment reports and testing results with specific attention to identifying unusual trends and actions that appear to have the potential for developing a security/safety problem.

March 2005- July 2007

Jun 1997-March 2005

Noven Pharmaceutical Inc, Miami, Florida

Documentation Lead

Identified needed improvements in operations, management, and controls. Demonstrated ability to credibly challenge and appropriately exercise authority in a collaborative environment.

Ensured compliance and adherence with company regulations, policies and procedures.

Tracked, assimilated, maintained, distributed and provided training on the GCP standards, guidelines, and references documents from all global regions that company was conducting clinical trials and also provided support to Internal Audit and External Audit as a GCP Auditor and GCP Subject Matter Expert.

Provided support and completed action item to help maintain the Clinical Trial Master File (CMTF) in a NDA ready status. Kept high level of safety awareness while performing on the job and comply with all safety absolutes. Developed documentation and provide product support for project management system.

Lead activities intended to identify root causes and remediation plans to address control gaps, optimize operational efficiency, and improve quality. Identified owners and monitor timely implementation of remediation plans. Worked with internal and external associates to ensure compliance with protocols, FDA regulation and clinical objective. Investigated threats and violations in development system.

Convergys’s Corporation Inc, Fort Lauderdale, Florida

Quality Assurance Supervisor

Monitored all employees’ calls on a daily basis. Participated in activities designed to improve customer satisfaction and business performance.

Interacted with search firms and employment agencies for higher level and/or more specialized candidate needs. Managed the resume tracking database, ensuring that it is up-to-date and accurate.

Responsible for selecting, training, developing, and managing performance of professional and non-exempt direct reports; providing prompt and objective coaching and counseling; and coordinating, planning, and assigning work for staff in accordance with the organization’s policies and applicable legal requirements. Oversees testing of applicants, reference checks, and pre-employment drug screens.

Ensured that suitable recruiting records and statistics are kept collaborates with management to fill their recruitment needs and ensure they are apprised of progress towards securing the requested personnel. Interviewed applicants for professional level positions, scheduling qualified candidates to meet with the hiring manager. Conducted employee evaluations once a year.

Continuing Education/ Honors & Activities

Member of Delta Epsilon Iota Academic Honor Society.

Proficient in Microsoft Word, Office, Excel, PowerPoint, Notes\Kronos, GDMS, SQL Server, Oracle, Track Wise.

References:

Thaina Garcia-Ward Azopharma Drug Development Services, Inc. Director

Phone Number: 305-***-****

Email Address:

Reference Type: Professional

Todd Person MERCK SHARP & DOHME Associate Director Regulatory &

Phone Number: 305-***-**** Compliance

Email Address: adxwc7@r.postjobfree.com

Reference Type: Professional

Lucy Cadet Barry University Counselor

Phone Number: 305-***-****

Email Address: adxwc7@r.postjobfree.com

Reference Type: Professional

Latasha Gibson Barry University Colleague

Phone Number: 786-***-****

Email Address: adxwc7@r.postjobfree.com

Reference Type: Personal

Dr. James Talerico Barry University Professor

Phone Number: 305-***-****

Email Address: adxwc7@r.postjobfree.com

Reference Type: Professional

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