Quality Engineer - GMP, Validation & Process Excellence

FITS, LLC; Añasco (PR); On-site; USD 55,000 - 75,000; Full time

Job summary

FITS, LLC is seeking a Quality Assurance professional to support QA activities in the Manufacturing/Engineering area. The role requires a Bachelor's degree in Engineering and 3+ years in the pharmaceutical or medical devices sectors, with bilingual English/Spanish communication.

The position follows an administrative shift aligned with business needs and involves working with GMP/GDP regulations. The candidate will help implement quality engineering processes for new products and assist in

Qualifications

• Bachelor's Degree in Engineering and at least three(3) years of exposure to Quality activities within the Pharmaceutical or Medical Devices industry.
• Bilingual, Spanish and English (good communication)
• Shift: Administrative & according to business needs
• Experience in: Validation Life Cycle, Change Control, Documentation, GMP & GDP regulations

Responsibilities

• Support the implementation of effective quality engineering processes for new products, processes, and technology.
• Provides support to the validation and certification of process, test methods, equipment, software, utilities, and facilities as required.
• Generates test protocols, monitors testing, issues qualification test reports and approves qualifications plans/reports.
• Provides support on activities, documents and records requiring Quality Engineering review and/or approval as deemed necessary.
• Alerts the organization to issues in time to resolve potential adverse effects on the customer, company image, or reputation of the business.
• Works with multi-functional teams to establish project plans and ensure uninterrupted support to new projects balanced with manufacturing operations.
• Develops standard operating procedures, specifications, and provides technical transfer and validation support.
• Utilizes appropriate risk management tools to prevent unanticipated failure modes and improve capability of processes.

Skills

Quality assurance

Bilingual Spanish/English

GMP & GDP knowledge

Education

Bachelor's degree in Engineering

Tools

Validation life cycle

Change control

Documentation

GMP & GDP compliance

Job description

FITS, LLC is seeking a Quality Assurance professional to support QA activities in the Manufacturing/Engineering area. The role requires a Bachelor's degree in Engineering and 3+ years in the pharmaceutical or medical devices sectors, with bilingual English/Spanish communication.

The position follows an administrative shift aligned with business needs and involves working with GMP/GDP regulations. The candidate will help implement quality engineering processes for new products and assist in