SUMMARY:

Extensive experience in FDA regulated industries which include GMP, GLP, GCP and GTP. Assisted numerous pharmaceutical and biotechnology companies in validation and qualification efforts of utilities, equipment and manufacturing processes. Conducted supplier audits for clients to ensure company and regulatory requirements are met. Assisted in compliance efforts by identifying gaps and implementing corrective and preventative action plans. Administered in - house Quality Assurance Program ( including monitoring employee records, calibration and equipment documentation and standard operating procedures).

PROFESSIONAL EXPERIENCE:

Confidential

SENIOR SPECIALIST GMP QUALITY ASSURANCE

Responsibilities:

• Responsible for managing and processing document changes for Vaccine Business Unit
• Serve as primary trainer for document change control process
• Collaborate with document authors and review panel to ensure quality procedures are effective in system
• Implement functional requirements for project teams in electronic system
• Performed script testing to support validation of electronic data management and electronic system

Confidential

DIRECTOR OF OPERATIONS

Responsibilities:

• Responsible for the management of all laboratory personnel
• Interface with Laboratory Managers, Sales and Marketing and Director of Finance to enhance communication between departments
• Communicate significant variances which alter the work schedule to study business group
• Create action plan to deal with variances to help control deviations from projected schedule
• Interface with multi-functional team members to resolve CAPA issues

Confidential

DIRECTOR OF QUALITY ASSURANCE

Responsibilities:

• Performed Quality Assurance review of distribution records to ensure traceability of product
• Responsible for maintaining the Document Control System including change orders, document history files and controlled copies of Standard Operating Procedures
• Interfaced directly with FDA during facility audits and product recalls
• Developed and maintained in-house Quality Systems including facility internal audits, corrective action plans and complaints
• Maintained and monitored employee documentation, calibration documentation and equipment history files
• Developed programs for GMP as well as on Quality System procedures

DIRECTOR OF OPERATIONS

Confidential

Responsibilities:

• Responsible for customer service and distribution personnel
• Maintain traceability of all instruments and devices distributed to hospitals and clinics
• Inspection of medical devices and completion of device history records for clinical trial study
• Coordinate with clinical site monitors to reconcile inventory using Inventory Management System
• Maintain GMP and GTP compliance to meet regulatory requirements of the FDA
• Interface directly with the President, Customer Service Representatives and Distribution personnel to assure accurate, technically competent work

Confidential

DIRECTOR OF OPERATIONS

Responsibilities:

• Responsible for the management of all laboratory personnel
• Interface with Laboratory Managers, Sales and Marketing and Director of Finance to enhance communication between departments
• Maintain file of job estimate to actual job expenditures to evaluate areas of process improvement
• Communicate significant variances which alter the work schedule to study business group
• Create action plan to deal with variances to help control deviations from projected schedule

Confidential

BUSINESS DEVELOPMENT MANAGER

Responsibilities:

• Coordinated advertising and marketing activities
• Assisted in compiling technical information for demonstrations to communicate features and benefits of product
• Created company communications plan
• Supported additional follow-up with clients to maintain sales relationship
• Scheduled and coordinated on-site demonstrations
• Maintained company client database with current contact information

Confidential

TECHNICAL MANAGER, VALIDATION

Responsibilities:

• Supervised the performance qualification aspects of multiple validation projects, including staffing, scheduling and technical support
• Managed Performance Qualification personnel with duties including hiring recommendations, performance appraisals, and
• Developed time, material, and cost estimates for validation services contracts
• Performed audits of client facilities for GMP and regulatory compliance
• Developed validation master plans for client facilities and processes
• Coordinated with project engineers and calibration personnel to complete equipment qualification studies

QUALITY ASSURANCE SPECIALIST

Confidential

Responsibilities:

• Performed Quality Assurance review on protocols, final reports, standard operating procedures and validation master plans
• Administered in-house Quality Assurance Program including monitoring employee records, calibration documentation, and standard operating procedures
• Developed programs for GMP as well as on equipment use and test procedures
• Reviewed IQ, OQ and calibration equipment and utility documentation

VALIDATION SPECIALIST

Confidential

Responsibilities:

• Prepared performance qualification procedures, protocols and final reports and performed qualification test procedures on a wide variety of utilities, process equipment and support equipment in the biotech and parenteral drug fields
• Assisted with installation and operational qualification testing on utilities and equipment
• Provided clients with troubleshooting skills when problems occurred with processes or equipment
• Collected performance qualification samples for analysis

LABORATORY TECHNICIAN

Confidential

Responsibilities:

• Performed laboratory testing including sterility testing, bioburden analyses, LAL testing, and disinfectant testing, particulate analyses and USP water testing
• Performed quality control testing of raw materials, in-process items, and final products