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?
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