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QA Engineer

Flexible & Integrated Technical Services, LlcAñasco, Puerto Rico, United States

Hace 6 días

Descripción del trabajo

For Quality Assurance services in the Manufacturing area.

WHAT MAKES YOU A FIT :

The Technical Part :

Bachelor’s degree in Natural Science (Chemical or Biology preferred) or Engineering and a minimum of ten (10) years of exposure in Quality activities within the Pharmaceutical or Medical Device Industry.
Excellent verbal / written communication skills (English and Spanish)

Shift : Administrative & according to business needs

Experience in :

Validation Life Cycle

Change Control

Documentation

GMP & GDP regulations

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 take on this new challenge?

AS A PIECE OF FITS, YOU WILL : (The day-to-day on the job)

Support the implementation of effective quality engineering processes for new products, processes, and technology.

Provides support to the validation and certification of process, test methods, equipment, software, utilities and facilities as required.

Generates test protocols, monitors testing, issues qualification test reports and approves qualifications plans / reports.

Provides support on activities, documents and records requiring Quality Engineering review and / or approval as deemed necessary.

Alerts the organization to issues in time to resolve potential adverse effects on the customer, company image, or reputation of the business.

Works with multi-functional teams to establish project plans and ensures uninterrupted support to new projects balanced with manufacturing operations.

Develops standard operating procedures, specifications, and provides technical transfer and validation support.

Utilizes appropriate risk management tools to prevent unanticipated failure modes and improve capability of processes.

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?

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Engineer • Añasco, Puerto Rico, United States