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Director Of Validation Services Resume

Miramar Beach, FL

SUMMARY:

A results - oriented and quality-focused professional with a distinctive career emphasizing validation, quality assurance, technical writing, training, coaching, development, and leadership. A self-directed and driven professional with the ability to consistently solve problems and achieve objectives.

AREAS OF EXPERTISE:

  • System Validation
  • Quality Management
  • Documentation
  • Process Development
  • Strategic Analysis
  • Quality Assurance
  • Technical Writing
  • Project Planning
  • Process Improvement
  • Regulatory Compliance

EXPERIENCE:

Director of Validation Services

Confidential, Miramar Beach, FL

Responsibilities:

  • Provide strategic consulting to life science organizations
  • Assist in definition of critical short-term and long-term technology objectives
  • Assist with requirement definition and solutions evaluation
  • Advise on matters of system validation and implementation
  • Participate in recommendation and creation of business policies and procedures
  • Ensure regulatory compliance in business process and operation

QA/Validation Manager

Confidential, Woodridge, IL

Responsibilities:

  • Implement processes using effective QA methodologies and best practices to maintain quality standards, controls and procedures
  • Manage QA employees and resources
  • Enforce quality procedures during product development
  • Manage the updating of Implementation and other company guides
  • Manage the Development of User Requirements Documents, Functional Specification Documents and Release Notes
  • Communicate with customers regarding quality issues
  • Manage the development of the Test Plan and Test Summary Report for new releases
  • Manage the creation and execution of test cases for all changes
  • Set QA compliance objectives
  • Host vendor audits
  • Conduct internal audits
  • Implement CAPA and necessary remediation measures
  • Communicate test progress, statistics and results and other relevant information to management and other stakeholders
  • Manage validation projects
  • Create SDLC and validation deliverables including Validation Plan, User Requirements Specification, Functional Specifications Document, Operational/Performance Qualification, Requirements Traceability Matrix, and Validation Summary Reports as well as other documentation as determined by project
  • Validate software solutions developed by the company
  • Enforce quality procedures during product development and testing
  • Coordinate client validation activities
  • Organize UAT and pre-implementation efforts

Lead Validation Analyst

Confidential, Woodridge, IL

Responsibilities:

  • Manage validation projects.
  • Manage the creation of validation deliverables including Validation Plan, User Requirements Specification, Functional Specifications Document, Operational Performance Qualification, Requirements Traceability Matrix, and Validation Summary Reports as well as other documentation as determined by project.
  • Validate Confidential software solutions developed by the company.
  • Enforce quality procedures during product development and testing.
  • Manage the updating of implementation and company guides and Standard Operating Procedures.
  • Provide Quality and Regulatory training to employees.
  • Maintain training requirements and records for all internal employees. Coordinate client testing and validation activities
  • Organize UAT and pre-implementation efforts

Quality Assurance Analyst

Confidential, Woodridge, IL

Responsibilities:

  • Plan and design test strategies for Confidential software releases.
  • Write and maintain detailed functional and ad-hoc test procedures.
  • Manage and respond to software Quality Assurance issues with related groups such as Development, Project Management, and Technical Support with adherence to resolution processes and timelines.
  • Manually test technical, user, and functional requirements of Confidential software.
  • Troubleshoot, isolate, and escalate software and configuration defects.
  • Prepare and distribute formal test plans, test summary reports, and software release notes.

Technical Support Specialist

Confidential, Woodridge, IL

Responsibilities:

  • Provide client support and technical resolution via e-mail, phone, and internet.
  • Document problem, action steps, and resolution for client-identified issues.
  • Follow-up with clients regarding identified issues, resolutions, and upgrades as necessary.
  • Escalate issues for investigation and resolution by Development staff.
  • Troubleshoot, correct, advise, and train on operational issues in clients’ supported Confidential systems.
  • Configure clients’ hardware/software to work and integrate with Confidential application
  • Make recommendations regarding configuration of Confidential system to address changing business needs.

Training Manager

Confidential, Lisle, IL

Responsibilities:

  • Design, coordinate, and deliver training to newly hired employees in a contact center for the Illinois Tollway Authority.
  • Approve and audit settlement and chargeback amounts for tollway patrons.
  • Report training strategies and results to management and employment agency partners.

Senior Instructor

Confidential, Woodridge, IL

Responsibilities:

  • Coordinate, oversee, and monitor training and support functions of sales and service staff of over 500 employees.
  • Supervise and manage performance of employees during involvement in training program.
  • Participate in development through implementation phases of training curriculum for sales and customer service departments.
  • Design training curriculum for newly hired and incumbent licensed employees.
  • Conduct needs analyses for identification of performance and knowledge gaps to be improved through coaching and training.
  • Coordinated department’s first rotation program for enhancement of employee knowledge, career shadowing, and talent development.

Instructor

Confidential, Woodridge, IL

Responsibilities:

  • Train, develop, and coach newly hired employees in the areas of product, process, and system applications and ensure staff compliance with established policies and procedures.
  • Coordinate incumbent training workshops to support new initiatives, products, and processes while enhancing job skills of participants.
  • Support licensed insurance professionals with subject matter expertise.

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