Conducts a compliant validation process for quality information technology systems which requires formal validation documentation (including standard operating procedures) under appropriate federal regulations.
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.
Performs system administration and configuration of quality information technology systems.
Performs investigation non-conformance events
Availability to work overtime and weekends when necessary
Good problem-solving skills
Initiates, recommends, and provides solutions to the Non-Conforming Product as per procedures
Verifies the implementation and effectiveness of non-conforming CAPA
Executes job responsibilities as established in the procedures
Follows the documentation procedures Non- Conformance Resolution
Evaluating, Investigating & Completion of Non- Conformance
Investigation (Data gathering of Quality issue)
Identify Corrective/Preventive Actions
Implementing Corrective/Preventive Actions
Lead complaint activities with the Operating Units members
Bachelor Degree in Engineering
years of relevant experience
Fully Bilingual (English and Spanish)
Investigation and root cause analysis skills
Technical writing knowledge
Organization and Communication skills
Process Validation and Computer software validation knowledge
Lean Six Sigma Green Belt Certification
Microsoft Office (Excel, Word, Outlook, Power Point, Project) Agile, HR - ABRA Suite, Maximo, MRO Program, SAP, TEDS, Agile, Compliance Wire, Gallup On-line Tool and Factory works