Quality Applications Specialist-Juncos

Descripción del Empleo:
Conducts a compliant VALIDATION P ROCESSfor quality information technology systems which requires formal validation documentation (including standard operating procedures) under appropriate federal regulations. Coordinates activities with clients, programmers/developers and operating personnel, domestic and, as appropriate, global. Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation and maintenance of the procedures, actions and documentation necessary to assure compliance according to the appropriate federal and international regulations which govern the user's applications. Reports on the status of validation activities to fulfill regulatory requirements. Keeps abreast of changing federal and international regulatory requirements and government audit policies. 33935 - 3; 34029-2; 33886-1
Requisitos:
Bachelor's Degree in Engineering preferably Mechanical, Industrial, Electrical, Chemical, or Biomedical. Engineering License, Lean/Six Sigma Green or Black Belt Certification are
a plus. A MINIMUM of 3-5 years of validation activities experience is REQUIRED. Experience executing some or various of the following Validation/Qualification activities in medical device or pharmaceutical manufacturing: Software Validation, Computer Systems Validation (CSV), Raw Materials/Suppliers Qualifications, Cleaning Validation, Manufacturing/Packaging Equipment Validation, Lab Equipment Validation, Process Validation, Product Transfer, Method Transfer & Validation, Automation, Change control documentation. Proficient knowledge in the statistical analysis of data, evaluation, investigation and document non-conformance, use of Minitab.