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Senior Specialist Resume

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
Confidential

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
Confidential

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

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