Job Description

For Remediation services in the Quality Assurance area.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor’s Degree in Engineering and 5 years of experience in the review and approval of life cycle validation documentation in the regulated industry.
• Bilingual: Spanish and English
• Soft Skills: Attention to detail, organization, and writing skills
• Shift: Administrative, and according to the business
• Experience:
  • Quality assurance focused on reviewing validation cycle documentation, quality systems, procedures, change control, and design control.

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)

• Quality processes, including change assessments, process validations, and software validations, as well as experience in sterile packaging and labeling systems.
• Conduct and manage change assessments and process validations to ensure compliance with regulatory standards and company policies.
• Perform ESQ (Engineering Software Quality) and software validations to maintain high-quality software performance and reliability.
• Oversee sterile packaging processes, including final packing and labeling, ensuring adherence to safety and quality standards.
• Conduct inspections of labeling systems and processes to guarantee accuracy and compliance.
• Collaborate with cross-functional teams to identify and address quality issues, implementing corrective actions as needed.
• Utilize and maintain knowledge of systems such as Windchill, CAPA, MES, and BMRAM for effective quality management and documentation.

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 the well-being of our resources, while providing our Pharmaceutical, medical device, and Manufacturing industry clients with top-notch quality talent. We're FITS!

Are you the next piece?