Sr. Quality Application Specialist - 142

Flexible & Integrated Technical Services, LLC • Juncos, PR

22h

About The Position

For validation services in the Manufacturing area.
WHAT MAKES YOU A FIT:
The Technical Part:
Bachelor’s Degree in Engineering and (4) four years of experience within the Medical Devices Industry.
Bilingual: Spanish and English
Soft Skills: Excellent Team leader skills
Shift: Administrative, and according to business needs.
Experience in:
Test Method Validation (IQ/PD/OQ/PQ) and CSV
Documentation changes
Equipment Validation
Quality and Compliance
The Personality Part:
Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients, and team members. In other words, being a customer service pro is one of your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to Be The Piece?
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)
Conducts a compliant validation process for quality information technology systems, which requires formal validation documentation.
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.
Experience in the identification, implementation, and maintenance of the procedures, actions,s and documentation necessary to assure compliance.
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.
WHO WE ARE:
We are a Service Provider company, different from the rest. We pride ourselves on how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities, and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented, and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device, and Manufacturing industry clients with top-notch quality talent. We're FITS!
Are you the Next Piece?

Requirements

• Bachelor’s Degree in Engineering and (4) four years of experience within the Medical Devices Industry.
• Bilingual: Spanish and English
• Excellent Team leader skills
• Test Method Validation (IQ/PD/OQ/PQ) and CSV
• Documentation changes
• Equipment Validation
• Quality and Compliance

Responsibilities

• Conducts a compliant validation process for quality information technology systems, which requires formal validation documentation.
• 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.
• Experience in the identification, implementation, and maintenance of the procedures, actions,s and documentation necessary to assure compliance.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level