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 training records, calibration and equipment documentation and standard operating procedures).

PROFESSIONAL EXPERIENCE

Confidential

SENIOR SPECIALIST 

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 training requirements for project teams in electronic training system
• Performed script testing to support validation of electronic data management and electronic training system

Confidential, Bozeman, MT

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, Bozeman, MT

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 training documentation, calibration documentation and equipment history files
• Developed programs for GMP training as well as training on Quality System procedures

Confidential

DIRECTOR OF OPERATIONS

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, Bozeman, MT

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, Bozeman, MT

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, Bozeman, MT

TECHNICAL MANAGER

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 training
• 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

Confidential

QUALITY ASSURANCE SPECIALIST II

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 training records, calibration documentation, and standard operating procedures
• Developed programs for GMP training as well as training on equipment use and test procedures
• Reviewed IQ, OQ and calibration equipment and utility documentation

VALIDATION SPECIALIST

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

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

Confidential, Hamilton MT

QUALITY CONTROL SPECIALIST

Responsibilities:

• Performed Quality Control testing of raw materials, in-process materials, and final product
• Assisted in establishing a validation program for biotech facility