JT670 - SPECIALIST QA

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, a leader inthe pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

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
  

Qualifications:

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