Quality Specialist- 02

FITS, LLC; Juncos (PR); On-site; USD 65,000 - 90,000; Full time

Job summary

FITS, LLC is a service provider delivering engineering, construction, maintenance, utilities and specialized technical services across the Island (and in the US as well!). We are a flexible, family-oriented company that values the well-being of our resources while providing pharmaceutical, medical device and manufacturing industry clients with top-notch quality talent.

We are FITS! This role supports site quality programs by reviewing MPs, approving validation protocols, leading investigations,

Qualifications

• Bachelor's degree with four years of experience in pharmaceutical or regulated industry.
• Shift: Administrative shift, and according to business needs.
• Experience in quality organization supporting deviations, validation reports, qualifications, investigations.

Responsibilities

• Review and approve product MPs.
• Approve process validation protocols and reports for manufacturing processes.
• Request Quality on incident triage team.
• Release of sanitary utility systems. Approve planned incidents.
• Lead investigations. Lead site audits.
• Own site quality program procedures.
• Designee for QA manager on local CCRB.
• 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.

Skills

Quality systems

Deviations handling

Validation reports

Investigations

Education

Bachelor's degree

Job description

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor'sDegree with four(4)years of experiencewithin the pharmaceutical or regulated industry.
• Shift: Administrative shift, and according to business needs.
• Experience in:
  • Quality organization supporting deviations, validation reports, qualifications, investigations.

The Personality Part:

• Picture yourself in a lab… with all the equipment you need to put your multitasking, scientific, creative (to come up with all those experiments!) skills to work. Picture as well an environment of healthy competition, teamwork, being ethical and of using the scientific method in all ways possible. If you like how this sounds, then this might be the job for you. Bring it on!

AS A PIECE OF FITS, YOU WILL: (The 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.
• Release of sanitary utility systems. Approve planned incidents.
• Lead investigations. Lead site audits.
• Own site quality program procedures.
• Designee for QA manager on local CCRB.
• 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 companydifferent 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 industryclients with top-notch quality talent.We're FITS!