Senior QA Specialist: Validation & Compliance Leader

FITS LLC; Juncos (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

FITS LLC is seeking a QA professional for its technical team in Puerto Rico. The role focuses on validation, release, investigations, and maintaining site quality programs within the pharmaceutical and medical device sectors.

The candidate must be bilingual (English/Spanish) and bring project management experience to drive compliant processes. Join a service provider firm that supports engineering, construction, and manufacturing across the island and the US, with a culture built on integrity,

Qualifications

• Bachelor's degree with six years of experience in pharma or regulated industries.
• Bilingual in English and Spanish required.

Responsibilities

• Approve process validation protocols and reports for manufacturing processes.
• Represent QA on incident triage team.
• Approve Environmental Characterization reports.
• Release sanitary utility systems.
• Approve planned incidents.
• Represent QA on NPI team.
• Lead investigations.
• Own site quality program procedures.
• Designee for QA manager on local CCRB.

Skills

Bilingual English & Spanish

Project Management

Education

Bachelor's degree

Tools

KNEAT

CDOCS

SCADA

TrackWise

Maximo

Job description

FITS LLC is seeking a QA professional for its technical team in Puerto Rico. The role focuses on validation, release, investigations, and maintaining site quality programs within the pharmaceutical and medical device sectors.

The candidate must be bilingual (English/Spanish) and bring project management experience to drive compliant processes. Join a service provider firm that supports engineering, construction, and manufacturing across the island and the US, with a culture built on integrity,