CAPA Specialist - Technical Writing

For Quality Services in Utilities Operations and Maintenance.

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor’s degree in Natural Science or Engineering and five (5) years of exposure in the Pharmaceutical/Medical Devices industry. 
• Bilingual (English & Spanish)
• Shift: Administrative and according to business needs.
• Experience in:
  • Technical writing and good documentation practices. 
  • Quality Assurance from a utilities operations and maintenance perspective.
  • Managing quality investigations, CAPAs, Pest Control, HVAC and utilities.

The Personality Part:    

• Working under pressure, while exercising good judgement seems like a tough thing to pull off, but we know you’re a pro at this already. Add to this a commitment to serving customers with high-quality research and products, to embracing a diverse work culture, and even to the environment, you might just be what we’re looking for!

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

• Support programs to create value for clients to ensure program deliveries meet or exceed expectations Build successful relationships within the compliance, utility operation, engineering, and other client personnel to promote confidence, planning, and best practices.  
• Collaborate with account-wide team and proactively share and reapply all learnings, successes, and best practices.
• Manage quality investigations, CAPAs, nonconformance, and audit observation tasks required to support the maintenance of utility operations.
• Expected to interface with the client’s quality personnel to ensure that all of the client’s SOPs are followed, including GDP, Investigations and CAPA’s, and audits. Work performed by the team is documented and recorded correctly.
• Sustain quality assurance support and support the implementation of the Quality and Compliance program for a state-of-the-art pharmaceutical/ medical device manufacturing facility as it relates to the facilities maintenance of this plant.
• Report on critical & key performance measurements. Submit periodic task reports to management.
• Mentor, develop, and train peer and other team members.
• Provide direction/information to vendors, facilities staff, and service providers as required to ensure that quality assurance expectations are communicated and followed.
•  Any and all other duties and tasks assigned.

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?