Change Control Owner

For Change Control services 

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor’s Degree and five (5+) of previous experience in change control within the Pharmaceutical industry. 
• Excellent reading, writing, and speaking skills in Spanish and English.
• Shift: Administrative, and according to business needs.
• Experience in:
  • Trackwise platform
  • Change Control Management
  • Pharmaceutical Industry

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 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)

• Provide Change Control support for the Cordillera Project, acting as Change Control Owner.
• Generate and manage Change Controls in TrackWise based on system and equipment classification.
• Conduct meetings with SMEs to support Change impact assessments, obtain Change Ratings, and define Implementation Steps.
• Prepare informal Risk Assessments for Changes with SME support.
• Present Changes in required forums (Quality Board, EHS Board, Process Team meetings) for approval readiness.
• Follow up with approvers and update Change documentation per feedback.
• Prepare Change status reports and track Implementation Step execution.
• Coordinate with Step Executors to ensure timely completion of assigned actions.
• Generate Amendments and Extensions as required.
• Attend project meetings to support Change execution.
• Facilitate meetings with SMEs and Change Evaluators to support Step clarification and closure.
• Support and execute Implementation Steps as required based on expertise and access.
• Procure, review, and submit documentation required for Step closure.
• Oversight process flow of Project Change Requests (PCRs) in accordance with Global Facilities Delivery (GFD) Project Change Management procedures (GFD-SOP-606).
• Oversight PCR initiation, development, and lifecycle management ensuring inclusion of scope and change definition, cost, schedule, and design intent impact evaluations. Coordinator is responsible for following up and ensures appropriate resources defined in change procedure/process provide the information in a timely manner according to process expectations until completion of full document readiness to be presented at change board.
• Participate at cross-functional PCR impact assessments triage sessions with Project Management, Engineering, Quality, C&Q, EHS, and SMEs to understand changes needs moving forward as part of PCR generation process flow.

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?