Documentation Coordinator

Documentation Coordinator

Fits Llc





Documentation Coordinator

Detalles de la oferta

For documentation services in the quality area.

The Technical Part:
Bachelor's degree & one (1) year of exposure within the Pharmaceutical Industry.

Experience in:
Electronic Batch Record
Word, Excel, PowerPoint, Internet
EHS regulations and cGMP
Spanish/English communication

The Personality Part:
Being self-motivated means that you are curious, anxious to explore all possibilities without anyone telling you to (while also following instructions, of course). It means you're creative, with such an eye for detail that nothing gets past you. If this sounds like you, and if you have 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)

Coordinate activities to ensure manufacturing documentation integrity and compliance with the cGMP.
Comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices.
Print all applicable documentation from Documentation Control A (DCA) and SAP systems- label (lot number, product code and name).
Compare all batch records documentation versus production orders and BOM/BOS to assure the documentation corresponds to the product lot.
Verify that batch records, production orders and BOM/BOS data are the same if not report any discrepancy immediately to the corresponding department.
Generate cleaning checklist packages and distributes to Manufacturing supervisor ensuring that the cleaning forms are the current version approved.
Receives daily executed Batch Records, removes internal documentation and keeps all GMP documentation according required procedures.
Follow up to manufacturing areas to ensure documentation cycle time completion. Also, perform manufacturing documentation audits as scheduled.
Maintain, guard and handle all manufacturing files:Master Batch Records, Batch Record, Log Books, cleaning registers/checklists and executed forms.
Perform the report consumption of material, man hours, transfer orders (TO) and transfer request (TR) and train new hires.

One of these is the excellent, unmatched, never-before-seen customer service of our team (trust us, you'll be amazed). However, that's not all we have to offer. Talk with us to find out!
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?


Fuente: Simplyhired




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