Quality Specialist: Investigations, CAPA & Audits

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

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,