QA Specialist: Process Validation & Investigations Lead

ProQuality Network; Puerto Rico; Hybrid; USD 60,000 - 85,000; Full time

Job summary

ProQuality Network is seeking a Specialist QA to support the Quality Assurance program with minimal supervision. You will perform diverse quality activities across manufacturing, validation, investigations, documentation, and compliance.

The role requires experience in change control, documentation review, process validation, and PPQ, with responsibilities spanning MPs, CAPA, incident triage, NPI participation, and release of systems. Hybrid schedule in Puerto Rico is expected.

Qualifications

• Excellent organizational skills and ability to manage assignments end-to-end.
• Ability to initiate and lead cross-functional teams.
• Strong leadership, influencing, and negotiation skills.
• Proficiency with standard office software (word processing, spreadsheets, presentations).

Responsibilities

• Review and approve product Master Plans (MPs).
• Approve process validation protocols and reports for manufacturing processes.
• Participate as QA representative on incident triage teams.
• Review and approve Environmental Characterization reports.
• Release sanitary utility systems.
• Review and approve planned incidents.
• Represent QA on New Product Introduction (NPI) teams.
• Lead quality investigations.
• Own and maintain site Quality Program procedures.
• Serve as QA Manager's designee on CCRB.
• Support automation-related activities.
• Support Facilities and Environmental programs.
• Review and approve Work Orders.
• Review and approve EMS/BMS alarms.
• Approve NC investigations and CAPA records.
• Review and approve Change Controls.
• Provide lot disposition and authorize lots for shipment.

Skills

Organizational skills

Cross-functional teamwork

Leadership

Communication

Education

Master's degree + 2 years related experience

Bachelor's degree + 4 years related experience

Associate degree + 8 years related experience

High school diploma/GED + 10 years related experience

Job description

ProQuality Network is seeking a Specialist QA to support the Quality Assurance program with minimal supervision. You will perform diverse quality activities across manufacturing, validation, investigations, documentation, and compliance.

The role requires experience in change control, documentation review, process validation, and PPQ, with responsibilities spanning MPs, CAPA, incident triage, NPI participation, and release of systems. Hybrid schedule in Puerto Rico is expected.