Senior QA Specialist: Quality Assurance Leader

ProQuality Network; Juncos (PR); On-site; USD 85,000 - 115,000; Full time

Job summary

ProQuality Network in Juncos, Puerto Rico seeks a Senior Specialist, Quality Assurance to provide technical QA oversight across manufacturing, validation, investigations, environmental characterization, and NPI activities. The role supports QA governance and acts as the designated representative for the QA Manager on the local CCRB.

The candidate will lead quality investigations, review MPs and validation reports, and collaborate with cross-functional teams to ensure compliant product releases

Qualifications

• Doctorate or relevant advanced degree with experience in QA for manufacturing
• Advanced knowledge of QA systems, validation, investigations, and NPI
• Experience supporting Change Control Review Board (CCRB) and QA governance
• Proven ability to lead cross-functional teams and manage projects
• Strong written and verbal communication, presentation skills
• Regulatory interaction experience (FDA, EMA, or equivalent)

Responsibilities

• Review and approve MPs and validation protocols and reports
• Represent QA on incident triage and NPI teams
• Lead quality investigations from initiation to closure
• Own site QA procedures and CCRB designee responsibilities
• Provide technical guidance across QA, validation, and manufacturing
• Trend and evaluate data to identify quality and compliance opportunities

Skills

Project management

Cross-functional teamwork

Regulatory knowledge

Leadership

Communication

Education

Doctorate degree

Master's degree

Bachelor's degree

Associate's degree

High school diploma

Job description

ProQuality Network in Juncos, Puerto Rico seeks a Senior Specialist, Quality Assurance to provide technical QA oversight across manufacturing, validation, investigations, environmental characterization, and NPI activities. The role supports QA governance and acts as the designated representative for the QA Manager on the local CCRB.

The candidate will lead quality investigations, review MPs and validation reports, and collaborate with cross-functional teams to ensure compliant product releases