Associate Quality Application Specialist - 130

Posted 8 Days Ago
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Juncos
In-Office
130K-130K Annually
Entry level
Pharmaceutical
The Role
Conduct compliant validation processes for quality IT systems, coordinate with clients and programmers, and ensure regulatory compliance.
Summary Generated by Built In

For Quality services in the Quality area.

WHAT MAKES YOU A FIT: 

The Technical Part:

  • Bachelor’s Degree in Life Sciences or Engineering and previous exposure within 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 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

Agile System
Capa
Factoryworks System
Sap Qm Module
Six Sigma
Trackwise Systems
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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