Senior QA Specialist – GMP & Change Control

Quality Consulting Group, LLC; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

QUALITY CONSULTING GROUP, LLC in Puerto Rico and the USA is seeking a talented QA professional to join our team. You will review, approve, and maintain manufacturing process documentation in compliance with cGMP, and lead investigations, CAPA development, and change control activities across a world-class manufacturing environment.

You will participate as a Quality representative on incident triage teams, support environmental characterization and sanitary utility systems, and contribute to NPI

Qualifications

• BS in Science, Engineering, Physics, Biology, Chemistry or related field.
• Experience in Change Control, Documentation Review, Validation & PPQ.
• Administrative Shift.

Responsibilities

• Review, approve, and maintain manufacturing process documentation (MPs) in compliance with cGMP requirements
• Review, approve, and ensure accuracy, completeness, and traceability of GMP documentation, including protocols, reports, investigations, and quality records
• Approve process validation protocols and reports, including PPQs and cleaning validation documentation
• Participate as Quality representative on incident triage teams, ensuring timely and compliant decision-making
• Review and approve planned incidents, deviations, and nonconformances, ensuring appropriate risk assessment and documentation
• Approve Environmental Characterization and environmental monitoring reports
• Release and maintain compliance of sanitary utility systems
• Represent Quality Assurance on New Product Introduction (NPI) teams
• Lead and document investigations, root cause analyses, and CAPA development
• Lead and support site audits, including internal, external, and regulatory inspections
• Own, maintain, and continuously improve site quality program procedures
• Serve as QA Manager designee on the local Change Control Review Board (CCRB)
• Review and approve risk assessments and mitigation strategies
• Support automation systems, including review of validation and change documentation
• Support facilities, utilities, and environmental compliance programs

Skills

Change Control

Documentation Review

Validation

PPQ

Education

BS in Science, Engineering, Physics, Biology, Chemistry or related fields

Job description

QUALITY CONSULTING GROUP, LLC in Puerto Rico and the USA is seeking a talented QA professional to join our team. You will review, approve, and maintain manufacturing process documentation in compliance with cGMP, and lead investigations, CAPA development, and change control activities across a world-class manufacturing environment.

You will participate as a Quality representative on incident triage teams, support environmental characterization and sanitary utility systems, and contribute to NPI