QA Associate

Extensive experience in auditing processes and procedures of laboratory and manufacturing (medical devices).Demonstrated ability in problem solving and communication. Familiar with validation requirements for equipment, software and facilities. Steady reliable Team Player with reputation for attention to detail. Team leader who provides motivation, training and driving support in troubleshooting.

AREAS OF STRENGTH

Self-Directed • Operations Supervision • Regulatory Compliance • Problem Resolution

PROFESSIONAL EXPERIENCE

Abound Insurance Agency August 2009-Present

Clerical Assistant

Correspond with clients, mortgage companies and banks requesting payments on insurance renewals. Perform Insurance Quotes. Additional clerical duties as needed.

US Census Bureau March 2009-May 2009

Crew Leader (Temp)

Performed training for new hires. Responsible for assigning areas for Staff of 20 Enumerators to perform canvassing and verifying addresses throughout the community. Performed payroll and monitoring of assignments daily. Responsible for $45,000 worth of Government equipment.

Unity Tax Services Jan 2009-Feb. 2009

Tax Preparer

Responsible for filing personal 2008 income tax for clients

Addeco, Ft. Lauderdale, Florida May 2006-Nov. 2008

Senior Quality Assurance Scientist

Perform detailed audits of practices at company to ensure that policies and procedures comply with guidelines set forth in the Food and Drug Administration (FDA) manual. Reports on weaknesses, ineffective procedures, policy exceptions and discrepancies and recommends appropriate corrective actions.

- Consults with Engineering, Software, Hardware, Algorithm and Manufacturing, to establish practices and procedures that comply with FDA regulations and Corporate Compliance Policies.

- Conduct requested audits of specific products, processes, or areas which include investigation, evaluation, and confirmation of follow-up.

-Responsible for working with QA management/teams on validations, protocol and process reviews, and implementation of requirements in compliance programs.

Key Achievements

Instrumental in finding major errors that resulted in the rewrite of instrument service manuals. Completion of Assessment Reports in a timely manner.

Inner City Children’s Theater Dance Company Feb 2005- June 2006

Administrative Assistant

Worked closely with the Executive Director assisting with the composition of grants and letters. Generation of forms. Eighty percent (80%) of grants were funded. Assisted group with the organizing of documents for easier access. Souvenir Book was completed in time for print and production.

ZLB PLASMA SERVICES, Miami, Florida Sept. 2000–July 2004

Compliance Analyst

Responsible for review of Quality Records in assigned departments.

Identify and report nonconformities of quality compliance to area management to ensure appropriate corrective action is initiated. Monitor timeliness of corrective action implementation to ensure compliance with procedural guidelines. Conduct follow-up inspections to verify efficacy of corrective action plans.

Suggested and facilitated implementation of process changes designed to correct problems noted during trend analysis.

Key Achievements

No nonconformities from external auditors.

Improved awareness to laboratory personnel on compliance. Updated and improved monthly reports with distribution to Management and Staff

NABI, Miami, Florida

Compliance Specialist Sept 1996–Aug 2000

Responsible for monthly audits of all laboratory and manufacturing operations. Served as Auditor for Miami Lab of all procedures during a mock BLA/PLA audit in, which observations of gaps were noted.

Responsible for review of Quality Records. Responsible for review of Manufacturing and Laboratory Batch Records. Assisted Management in the development of metrics to be used as performance indicators.

Participated in monthly Management Review Meetings (Compliance Evaluation Committee) and informed committee of outstanding Corrective Action items.

Key Achievements

Instrumental in broadening Customer Complaint

documentation, which resulted in an Access database and a 3-day response to customer.

BLA/PLA (FDA) audit passed. All procedures were revised with a recommendation of an annual review by management.

EDUCATION

University of Georgia, Athens, GA

Barry University, Miami, Florida B.S. Degree Laboratory Science/Biology Pending

COMPUTER SKILLS

Access • Excel • Word • Power Point • Outlook • Lotus Notes • Publisher

LICENSES / CERTIFICATES

State of Florida Notary Public

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