Electric Batch Record Specialist

For Software Integration services in the Manufacturing area. 

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor’s degree in Science or Engineering and Five (5) years of experience in the Quality or Manufacturing area within the Pharmaceutical & Medical Devices Industry.
• Bilingual: Spanish and English
• Soft Skills: Excellent Communication skills, and Positive attitude. 
• Shift: 1st Shift
• Experience in:
  • Electronic Batch Record Review.
  • Quality or Manufacturing experience.
  • Trackwise system.
  • GMP & GDP regulations.

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 Be The Piece?

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

• Active participation in IDS/TSMS team meetings to provide input on project timeline considerations, activities, escalations, and status of assigned tasks.
• Evaluate paper forms, process and equipment cleaning instructions, and logbooks to convert into electronic records. 
• Assess work centers used in production areas and equipment capability. 
• Serve as Subject Matter Expert to help the recipe authors construct documentation and suggest a path forward. 
• Revise and approve configuration documents.
• Participate in the revision of the flow charts of the documentation records related to the manufacturing stages and steps.
• Lead and/or participate in triage activities to assess change control requirements. 
• Issuance change control and present it to Change Control Board to pursue approval of the change. 
• Review documentation associated with PMX production procedures (Core documents and their Attachments – Visio, Master Data, EQM, Choice list.
•  Execute Test Scripts (informal), identify test script errors, and correct test script errors.  
• Issuance of Stabilization forms that may arise after transitioning from paper records to electronic records. 
• Revise equipment cleaning instructions while transferring them to electronic forms

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?