Senior QA Specialist: NPI & Manufacturing Quality Lead

ProQuality Network; Juncos (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

ProQuality Network seeks a Senior Specialist QA in Juncos, PR to support manufacturing and quality operations onsite. The role focuses on reviewing manufacturing docs, leading investigations, and supporting compliance across QA systems.

The candidate will represent QA on incident triage, approve validation reports, and participate in environmental characterization and change controls, with a 1-year contract and on-site schedule.

Qualifications

• Qualifications must match one of the degree/experience combos listed.
• Experience in QA within manufacturing, quality systems, and validation.
• Ability to lead investigations and QA on NPI.
• Strong documentation practices and data integrity.
• Experience with regulatory interactions.

Responsibilities

• Approve process validation protocols and reports for manufacturing processes.
• Represent QA on incident triage teams.
• Approve Environmental Characterization Reports.
• Support the release of sanitary utility systems.
• Approve planned incidents.
• Represent QA on New Product Introduction teams.
• Lead quality investigations.
• Own site Quality program procedures.
• Serve as QA Manager's designee on CCRB.

Skills

Project management

Cross-functional teams

Leadership

Regulatory knowledge

Documentation & data integrity

Quality systems

Validation

NPI

Communication skills

Process development

Education

Doctorate + 2 years of directly related experience

Master’s Degree + 4 years of directly related experience

Bachelor’s Degree + 6 years of directly related experience

Associate Degree + 10 years of directly related experience

High School Diploma/GED + 12 years of directly related experience

Tools

KNEAT

CDOCS

SCADA

TrackWise

Maximo

Job description

ProQuality Network seeks a Senior Specialist QA in Juncos, PR to support manufacturing and quality operations onsite. The role focuses on reviewing manufacturing docs, leading investigations, and supporting compliance across QA systems.

The candidate will represent QA on incident triage, approve validation reports, and participate in environmental characterization and change controls, with a 1-year contract and on-site schedule.