Bilingual Quality Technician – Pharma/Med Device

FITS LLC; Añasco (PR); On-site; USD 42,000 - 62,000; Full time

Benefits offered by this job

Excellent customer service team

Job summary

FITS LLC in Puerto Rico is seeking a Quality Technician to help define and specify activities, processes and standards to fulfill quality requirements for materials, components or products.

You will manage documentation changes, support sterilization qualification activities, audit and monitor manufacturing processes, and engage with customers and vendors to resolve quality issues while ensuring compliant workflows.

Qualifications

• Bachelor's Degree and at least 1 year of exposure in Pharmaceutical or Medical Device industry.
• Knowledge of GMP and GDP regulations.
• Bilingual in English and Spanish.
• Shift: Administrative and per business needs.

Responsibilities

• Define and specify activities, processes and standards to fulfill quality requirements for materials, components or products.
• Manage changes in documentation and provide training as applicable.
• Support sterilization process qualification activities.
• Audit, monitor and determine quality of manufacturing processes and outputs against internal and regulatory standards.
• Ensure efficient and effective workflow, procedures, policy and inspection programs.
• Manage in-process product quality with vendors and communicate with customers/vendors to resolve quality-related issues.
• Report and troubleshoot manufacturing process deviations and defects in finished goods.
• Use measuring devices, testing equipment and prescribed specifications to accept or reject materials and products related to sterilization.

Skills

Bilingual (English/Spanish)

GMP/GDP knowledge

Quality Assurance

Education

Bachelor's Degree

Job description

FITS LLC in Puerto Rico is seeking a Quality Technician to help define and specify activities, processes and standards to fulfill quality requirements for materials, components or products.

You will manage documentation changes, support sterilization qualification activities, audit and monitor manufacturing processes, and engage with customers and vendors to resolve quality issues while ensuring compliant workflows.