Quality Engineer - 119

Posted 17 Days Ago
Be an Early Applicant
Villalba
In-Office
Mid level
Pharmaceutical
The Role
Conduct validation processes for quality IT systems, coordinating with clients and maintaining compliance with regulations. Report on validation activities and keep up with regulatory changes.
Summary Generated by Built In

For Quality services in the Manufacturing area.

WHAT MAKES YOU A FIT: 

The Technical Part:

  • Bachelor’s Degree in Engineering and three (3) years of exposure within the Pharmaceutical & Medical Devices Industry.
  • Bilingual: Spanish and English
  • Soft Skills: Excellent Communication skills
  • Shift: 1st Shift. 
  • Experience in:
    • Process Validation
    • Statistical Techniques
    • Process Failure Mode and First Time Quality

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 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 ensure 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 company different 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 industry clients with top-notch quality talent. We're FITS! 

Are you the Next Piece?

Top Skills

Process Validation
Quality Information Technology Systems
Statistical Techniques
Am I A Good Fit?
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The Company
HQ: Guaynabo, PR
76 Employees
Year Founded: 2008

What We Do

We are a Service Provider company different 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 industry clients with top-notch quality talent. We're FITS!

Are We The Right Piece For You?
We are:

Experienced and knowledgeable in the Industry
Committed to Safety
Always compliant with FDA Regulations & Audits
Cost Effective
Proven successful track record
Over ten (10) years of experience

If you'd like to apply to any of our open positions, send us your updated resume in Word or PDF Format to [email protected]

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