Sr. Quality Systems Specialist - 013

For Engineer services in the Quality 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, and Positive attitude. 
• Shift: 1st Shift
• Experience in: 
  • Process Validation and Computer Software Validation.
  • Trackwise application.
  • Investigation and Root Cause Analysis. 
  • GMP and GDP Regulations.

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

• Provides oversight for the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies.
• Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and agency guidelines to assure compliance.
• Works directly with operating entities to provide process analysis oversight continuingly to enforce requirements and meet guidelines.
• Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages.
• Coordinates legal requests in support of government investigations or litigations.
• Ensures the quality assurance programs and policies are maintained and modified regularly.
• Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of the company's mission globally. 

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?