Quality Applications Specialist

Job Description Conducts a compliant validation process for 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, government audit policies, and the availability of current techniques.
Performs system administration and configuration of quality information technology systems.
Other duties may be assigned.
Quality resources to support product transfer activities such as: Layout, Equipment Qualification, Test Method, Process Validation, Plan and Report development and approval.
Requirements Minimum 2 years of experience working with Quality in the regulated industry.
Experience in Process Validation, Statistical Knowledge, Minitab and SAP.  Bachelor Degree in Engineering Completed.
Bilingual.
Willing to work On-site and weekends if necessary.
Requirements Minimum 2 years of experience working with Quality in the regulated industry.
Experience in Process Validation, Statistical Knowledge, Minitab and SAP.
Bachelor Degree in Engineering Completed.
Bilingual.
Willing to work On-site and weekends if necessary.