Quality Applications Specialist
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Job Location:
Juncos - Puerto Rico
Monthly Salary:
Not Disclosed
Posted on:
2 hours ago
Vacancies:
1 Vacancy
Job Summary
Summary
The Quality Applications Specialist supports quality systems and product transfer activities by ensuring compliant validation of computerized systems and manufacturing processes. The role focuses on sterilization equipment process validation and quality system compliance in regulated environments. This position works cross-functionally with engineering quality IT and operations teams to maintain compliance with federal and international regulatory requirements.
Responsibilities
- Conduct validation of Quality Information Technology Systems including preparation and execution of validation documentation.
- Develop and maintain validation protocols and documentation such as SOPs validation plans and reports.
- Ensure compliance with federal regulations and international quality standards governing computerized systems.
- Support product transfer activities with emphasis on sterilization equipment and processes.
- Coordinate validation activities with clients developers engineering teams and operational personnel.
- Monitor and report the status of validation activities to ensure regulatory compliance.
- Perform system administration and configuration for quality IT systems.
- Identify requirements for compliant computerized operations and implement procedures to maintain compliance.
- Maintain awareness of current regulatory requirements audit policies and industry best practices.
- Support quality improvement initiatives focused on First Time Quality (FTQ) and process efficiency.
*Other duties maybe assigned.*
Requirements
Minimum 3 to 6 years of relevant experience in quality validation or process engineering within regulated industries.
Bachelors Degree in Engineering completed.
Top 3 Key Qualifications:
- Knowledge of sterilization machines and sterilization processes
- Process validation experience
- Statistical analysis Process Failure Mode Analysis (pFMEA) and First Time Quality methodologies
Preferred Skills:
- Experience with process validation and quality system validation
- Knowledge of sterilization technologies
- Strong understanding of risk management tools (pFMEA)
- Experience with statistical analysis tools
- Familiarity with GMP and regulatory compliance environments
*Willing to work 100% on-Site in Villalba.
Company Industry
IT Services and IT Consulting
Key Skills
- Quality Assurance
- FDA Regulations
- Data Collection
- Food Safety Experience
- ISO 9001
- Mobile Devices
- Root cause Analysis
- Quality Systems
- OSHA
- Food Processing
- Quality Management
- cGMP
