Risk Management Specialist

For Quality Risk Management services in the Manufacturing area.

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor’s Degree in Life Sciences or Engineering and five (5) years of exposure within the Pharmaceutical or Medical Device Industry. 
• Excellent verbal/written communication skills (English and Spanish) 
• Shift: Administrative & according to business needs. 
• Experience in:
• Risk Management using several tools (FMEA, etc.)
• Developing cleaning validation studies 
• Protocols and reports

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)

• Active participation on Cleaning Validation team meetings to provide input on projects timeline considerations, activities, escalations and status of assigned tasks.
• Active participation on Contamination Control Strategy team meetings to provide input on activities, escalations and status of assigned tasks.
• Serve as Subject Matter Expert to lead Quality Risk Management exercises and author risk assessment reports. Responsible for implementation of identified actions.
• Serve as Subject Matter Expert to develop cleaning validation protocols, reports, executable instructions and implementation of additional data integrity requirements. 
• Participate in the revision of the cleaning and contamination control strategy documentation records related to the manufacturing stages and steps.
• Lead and/or participate on triage activities to assess change control requirements. 
• Issuance or support on change control generation.
• Issuance change control and present it in Change Control Board to pursue approval of the change. 
• Review documentation associated to contamination control strategy and cleaning program (cleaning validation master plan, risk assessment, protocols, reports, working instructions, sampling scheme, limit calculations, etc.).
• Revise SOPs related to cleaning program and contamination control strategy. 
• Lead trainings activities provided to manufacturing operators. 
• Comply with Individual Learning Plan Requirements including qualification modules for Darwin, Trackwise, VEEVA (Quality Docs) among others.
• Comply with additional tasks requested by supervisor.

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?