QA Specialist, cGMP/NPI & Regulatory – Life Sciences

Inteldot; Juncos (PR); On-site; USD 65,000 - 95,000; Full time

Job summary

Inteldot, a life sciences partner with operations across Puerto Rico, the US, Europe and Japan, seeks a Quality Assurance professional to support manufacturing, validation, and regulatory compliance. You will review deviations, CAPAs, and validation activities to ensure product quality and compliance on the floor.

Join a team that collaborates with Regulatory, Manufacturing, Validation, and Engineering to drive continuous improvement and effective quality management.

Qualifications

• Validated expertise in Quality Systems such as deviations, CAPA, and change control.
• Experience in computer systems validation or computer systems quality assurance for medical devices.
• Robust knowledge of manufacturing and distribution, QA, QAL, and Process Development.
• Experience with Validation Master Plan and IQ/OQ/PQ protocols, test scripts, and summary reports.
• Experience serving as Quality Contact for complex projects involving new products.
• Experience in commissioning and qualification.
• Strong organizational, communication, and presentation skills; ability to interact with regulatory agencies.
• Fluent in English and Spanish (written and oral).
• Data trending and evaluation abilities; ability to evaluate compliance issues.

Responsibilities

• On-the-floor review, approval, and tracking of cGMP processes, procedures, testing methods, documents, batch records, MES, EBR, SAP, EDMQ, DQMS, and Trackwise; incl. deviations, CAPAs, and validations.
• Lead continuous improvement initiatives and projects.
• Assess changes potentially impacting product quality per procedures.
• Ensure deviations are investigated and documented; ensure triage and records are current.
• Ensure production records and testing results are complete, accurate, and documented.
• Collaborate across Quality, Manufacturing, Process Development, Validation, QC, Warehouse, Engineering, and others per procedures.
• Serve as strategic advisor to senior management on quality, compliance, and safety risks.
• Support internal/external audits and inspections; act as Quality unit representative as needed.
• Ensure training compliance and task execution.
• Provide oversight for New Product Introduction (NPI).

Skills

Quality Systems

CAPA

Change control

GxP validation

IQ/OQ/PQ

Regulatory compliance

Quality Assurance

Process Development

Validation Master Plan

Deviations

Documentation

SAP

MES

Trackwise

English & Spanish

Education

Bachelor’s degree in Science or Engineering

Tools

SAP

Trackwise

EDMQ

DQMS

MES

EBR

Job description

Inteldot, a life sciences partner with operations across Puerto Rico, the US, Europe and Japan, seeks a Quality Assurance professional to support manufacturing, validation, and regulatory compliance. You will review deviations, CAPAs, and validation activities to ensure product quality and compliance on the floor.

Join a team that collaborates with Regulatory, Manufacturing, Validation, and Engineering to drive continuous improvement and effective quality management.