Specialist Quality Complaints F003

 For Quality services in the Site Complaints.

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor’s Degree with five (5) years of directly experience as Quality Professional in the regulated industry. 
• Bilingual (English & Spanish)
• Project Management skills
• Shift: Administrative and according to business needs
• Experience in:
  • Quality and manufacturing experience in biotech or pharmaceutical industry
  • Complaint Investigations
  • Manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device Manufacturing processes)

The Personality Part:

• Complaints…. Everybody has one, and no one can manage them like you can. You have a passion for getting to the root of the problem and satisfying your client’s need to fix it. Sprinkle on a love of the scientific method, teamwork and, above all else, being ethical and you just might have what it takes to take on this new challenge. Bring it on!

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

• Keep the complaints database updated as soon as factual information is available and summarize closed investigations into the database accurately.
• Ensure complaint related investigations are concise, clear and science-based by reviewing and approving such investigations.
• Follow-up on corrective actions derived from investigations through completion.
• On occasion, depending on the nature and complexity of the complaint, the specialist may be responsible of conducting and documenting the investigation.
• Therefore, the candidate must possess excellent writing skills that include closing the gap between a highly technical investigation into a simple and concise document that can be understood by non-technical reviewers.
• Communication and escalation of complaints, site representation on the product complaint network and generation and issuance of closure letters to patients and business partners.

BEING A FITS PIECE COMES WITH PERKS:

• One of these is the excellent, unmatched, never-before-seen customer service of our team (trust us, you’ll be amazed). However, that’s not all we have to offer. Talk with us to find out!

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?