Hybrid QA Specialist – GMP, NPI & CAPA

ProQuality Network; Juncos (PR); Hybrid; USD 60,000 - 90,000; Full time

Job summary

ProQuality Network seeks a Quality Assurance professional to support its QA program with minimal supervision. The ideal candidate will oversee QA activities across manufacturing, validation, environmental, facilities, and quality systems while partnering with cross-functional teams.

The role involves reviewing MPs, process validation protocols, change controls, and leading QA investigations. Hybrid schedule in PR with shift flexibility; 5-month contract available.

Qualifications

• Requires advanced knowledge of GMP and regulated manufacturing environments.
• Experience in reviewing and approving change controls, deviations, CAPAs, protocols, reports and procedures.
• Strong ability to lead cross-functional teams and interact with regulatory agencies.

Responsibilities

• Review and approve Master Production Records (MPs).
• Review and approve process validation protocols and reports for manufacturing processes.
• Participate as a Quality representative on incident triage teams.
• Review and approve Environmental Characterization reports.
• Support the release of sanitary utility systems.
• Review and approve planned incidents.
• Represent QA on New Product Introduction (NPI) teams.
• Lead quality investigations.
• Lead and support site audits.
• Own and maintain site Quality program procedures.
• Serve as QA Manager designee for CCRB.
• Review risk assessments.
• 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.
• Support lot disposition and authorize lots for shipment.

Skills

Project management

Cross-functional leadership

Leadership

Quality Assurance

Regulatory affairs

GMP

Communication

Data trending

Independent work

Education

Doctorate in a relevant field

Master’s degree + 2 years of related experience

Bachelor’s degree + 4 years of related experience

Associate degree + 8 years of related experience

High school diploma/GED + 10 years of related experience

Job description

ProQuality Network seeks a Quality Assurance professional to support its QA program with minimal supervision. The ideal candidate will oversee QA activities across manufacturing, validation, environmental, facilities, and quality systems while partnering with cross-functional teams.

The role involves reviewing MPs, process validation protocols, change controls, and leading QA investigations. Hybrid schedule in PR with shift flexibility; 5-month contract available.