FITS, LLC
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For QA services in the DP Quality Assurance area.
What makes you a fit: The Technical Part
Bachelor’s degree in sciences with four(4) years in the regulated industry.
Shift: Administrative and according to business needs.
Experience in:
New Product Introduction (NPI).
Change Control process.
FATs, Validation and PPQs.
For QA services in the DP Quality Assurance area.
What makes you a fit: The Technical Part (Bilingual)
Bachelor’s degree in sciences with four(4) years in the regulated industry.
Bilingual (English & Spanish)
Project Management skills
Shift: Administrative and according to business needs.
Experience in:
New Product Introduction (NPI).
Change Control process.
FATs, Validation and PPQs.
The Personality Part
Being self-motivated means that you are curious and 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 commit to serving customers with high-quality research and products, embracing a diverse work culture, and even the environment, you might just be what we’re looking for!
Role Responsibilities (Day-to-day on the job)
Review and approve product MPs.
Approve process validation protocols and reports for manufacturing processes.
Request Quality on incident triage team.
Approve Environmental Characterization reports.
Release of sanitary utility systems.
Approve planned incidents.
Represent QA on NPI team.
Lead investigations.
Lead site audits.
Own site quality program procedures.
Designee for QA manager on local CCRB.
Review Risk Assessments.
Support Automation activities.
Support facilities and environmental programs.
Review and approve Work Orders.
Review and approve EMS/BMS alarms.
Approve NC investigations and CAPA records.
Approve change controls.
Provide lot disposition and authorize lots for shipment.
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?
#J-18808-Ljbffr
Get AI-powered advice on this job and more exclusive features.
For QA services in the DP Quality Assurance area.
What makes you a fit: The Technical Part
Bachelor’s degree in sciences with four(4) years in the regulated industry.
Shift: Administrative and according to business needs.
Experience in:
New Product Introduction (NPI).
Change Control process.
FATs, Validation and PPQs.
For QA services in the DP Quality Assurance area.
What makes you a fit: The Technical Part (Bilingual)
Bachelor’s degree in sciences with four(4) years in the regulated industry.
Bilingual (English & Spanish)
Project Management skills
Shift: Administrative and according to business needs.
Experience in:
New Product Introduction (NPI).
Change Control process.
FATs, Validation and PPQs.
The Personality Part
Being self-motivated means that you are curious and 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 commit to serving customers with high-quality research and products, embracing a diverse work culture, and even the environment, you might just be what we’re looking for!
Role Responsibilities (Day-to-day on the job)
Review and approve product MPs.
Approve process validation protocols and reports for manufacturing processes.
Request Quality on incident triage team.
Approve Environmental Characterization reports.
Release of sanitary utility systems.
Approve planned incidents.
Represent QA on NPI team.
Lead investigations.
Lead site audits.
Own site quality program procedures.
Designee for QA manager on local CCRB.
Review Risk Assessments.
Support Automation activities.
Support facilities and environmental programs.
Review and approve Work Orders.
Review and approve EMS/BMS alarms.
Approve NC investigations and CAPA records.
Approve change controls.
Provide lot disposition and authorize lots for shipment.
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?
#J-18808-Ljbffr