Quality Validation Specialist

For Validations services in the Quality area.

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor’s Degree in Science with three to five (3 - 5) years of validation experience and exposure within the Pharmaceutical or Medical Devices industry. 
• Excellent reading, writing, and speaking skills in Spanish and English.
• Shift: Administrative and according to business needs
• Experience in:
  • Ensure all validation activities are documented accurately and comply with regulatory requirements and industry standards.
  • Review and approve validation protocols and reports to ensure they meet quality standards.
  • Identify opportunities for improving validation processes and implement changes to enhance efficiency and effectiveness.
  • Investigations, Deviations process and Non-conformance.

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 take on this new challenge?

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

• Ensure all validation activities, including protocols and reports, are meticulously documented, accurately executed, and comply fully with regulatory requirements (e.g., FDA, EU GMP) and industry standards.
• Review and approve validation documentation to ensure robust quality standards are met.
• Proactively identify and implement improvements to existing validation processes, enhancing their efficiency, effectiveness, and compliance.
• Actively partner with Quality Assurance, Manufacturing, and Engineering teams to seamlessly coordinate validation activities and ensure integrated operational excellence.
• Support and, when necessary, lead investigations for quality notifications (e.g., deviations, non-conformances, complaints). This includes authoring investigation reports, conducting thorough root cause analyses, and formulating effective Corrective Actions/Preventive Actions (CAPAs).
• Collaborate closely with manufacturing and technical services teams to troubleshoot and resolve complex process and product-related issues.
• Work effectively with cross-functional partners to execute remediation plans and CAPAs, ensuring timely closure of investigations and sustained compliance.
• Ensure all investigations and complaints are drafted to meet site-specific timelines and are completed before the impacted product(s) release.
• Coordinate and ensure the involvement of cross-functional teams with appropriate subject matter expertise when necessary, to facilitate thorough and effective investigations.

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?