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FITS LLC

Associate Quality Application Specialist - 130

FITS LLC, Juncos, Juncos, us, 00777

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For Quality services in the Quality area.

WHAT MAKES YOU A FIT: The Technical Part:

Bachelor’s Degree in Life Sciences or Engineeringand previous exposurewithin the Pharmaceutical & Medical Devices Industry.

Bilingual: Spanish and English

Soft Skills: Excellent Communication skills

Shift: 1st Shift.

Experience in:

Six Sigma, CAPA, and Product Nonconformance

SAP QM Module.

TrackWise Systems

Agile System and FactoryWorks System

Working in regulated industries

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 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 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.

Identification, implementation, and maintenance of the procedures, actions, and documentation necessary to assure compliance according to the regulation.

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 companydifferent from the rest. We pride ourselves in 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 industryclients with top-notch quality talent. We're FITS!

Are you the Next Piece? #J-18808-Ljbffr