Associate Quality Application Specialist
Share
Job Location:
Juncos - Puerto Rico
Monthly Salary:
Not Disclosed
Posted on:
10 days ago
Vacancies:
1 Vacancy
Job Summary
The Associate Quality Application Specialist supports the validation administration and compliance of quality-related computerized systems in a regulated environment. This role assists with validation documentation system configuration and cross-functional coordination to ensure compliance with applicable federal and international regulations.
Responsibilities
Support compliant validation processes for quality information technology systems in accordance with federal and international regulations.
Assist in the preparation execution and maintenance of validation documentation including SOPs protocols and reports.
Coordinate validation activities with Quality IT Engineering and business users including domestic and global stakeholders as applicable.
Identify current and anticipated requirements for compliant computerized operations.
Support the implementation and maintenance of procedures actions and documentation required to ensure system compliance.
Track and report the status of validation activities to support regulatory and audit requirements.
Maintain awareness of changing regulatory requirements audit policies and validation best practices.
Perform system administration and configuration of quality IT applications under guidance.
Support continuous improvement initiatives related to quality systems and applications.
Perform other duties as assigned.
Requirements
Minimum Requirements (Must Have)
Bachelors degree in Science or Engineering
Bilingual: English and Spanish
03 years of exposure to medical clinical or regulated environments (academic or professional)
Preferred Qualifications (Nice to Have)
Knowledge of Six Sigma CAPA and Product Non-conformance
Exposure to SAP QM Module
Experience with TrackWise systems
Familiarity with Agile systems and FactoryWorks
Knowledge or academic exposure to regulated industries (FDA GMP ISO etc.)
*Willing to work 100% On-Site in Juncos PR.*
Company Industry
IT Services and IT Consulting
Key Skills
- Laboratory Experience
- SQL
- Accounts Receivable
- .NET
- DICOM
- Cash Application
- Product Demos
- Sonography
- Customer Support
- Medical Imaging
- Technical Support
- Application Support
