Senior QA Specialist - Validation & Investigations

Quality Consulting Group, LLC; Juncos (PR); On-site; USD 80,000 - 110,000; Full time

Job summary

Quality Consulting Group, LLC seeks a motivated QA professional to join our team in Puerto Rico & USA. You will approve validation protocols, participate in incident triage, and lead QA investigations to sustain world-class manufacturing standards.

The role demands a bachelor's degree with 6 years of related experience, expertise in commissioning, qualification, and computer validation, and strong risk management and documentation practices to ensure regulatory compliance.

Qualifications

• Bachelor's degree and 6 years of directly related experience.
• Facilities and Utilities Commissioning and Qualification.
• Computer System Validation.
• Equipment validation.
• Risk Assessments.
• Good Documentation Practices, Data Integrity.
• Change Controls.
• Standard Operating Procedure development.
• Syringe/Vials inspection process.
• Documents revision and approval.
• Strong knowledge in decision making techniques.
• Risk management related to quality standards and regulatory requirements.

Responsibilities

• Approve process validation protocols and reports for manufacturing processes.
• Represent Quality on incident triage team.
• Approve Environmental Characterization reports.
• Release of sanitary utility systems.
• Approve planned incidents.
• Represent QA on NPI team.
• Lead investigations.
• Own site quality program procedures.
• Designee for QA manager on local CCRB.
• Project management skills.
• Strong knowledge of manufacturing, QA, validation, and process development.

Skills

Quality Assurance

Process validation

Risk assessment

Documentation

Education

Bachelor's degree plus 6 years experience

Tools

KNEAT

CDOCS

SCADA

TRACKWISE

MAXIMO

Job description

Quality Consulting Group, LLC seeks a motivated QA professional to join our team in Puerto Rico & USA. You will approve validation protocols, participate in incident triage, and lead QA investigations to sustain world-class manufacturing standards.

The role demands a bachelor's degree with 6 years of related experience, expertise in commissioning, qualification, and computer validation, and strong risk management and documentation practices to ensure regulatory compliance.