GMP Quality & Validation Specialist

Quality Consulting Group, LLC; Juncos (PR); On-site; USD 70,000 - 110,000; Full time

Job summary

Quality Consulting Group, LLC is seeking a talented, highly motivated quality professional to join our team in Puerto Rico and the USA, contributing to world-class manufacturing quality and environmental monitoring programs.

You will support deviations, change controls, CAPAs, and validation activities, preparing GMP documentation and reports. Collaboration with cross-functional teams and participation in audits are expected, ensuring compliance with cGMP and applicable regulations.

Qualifications

• Experience with GMP quality systems and handling deviations, change controls, CAPAs, and GMP documentation management.
• Proven ability in validation, commissioning and qualification (IQ/OQ/PQ) of manufacturing equipment and laboratory instrumentation, including testing.
• Strong technical writing skills and review/approval of GMP documentation, reports, procedures, protocols, and forms.
• Solid understanding of cGMP, FDA regulations, and industry best practices for validation and quality compliance.

Responsibilities

• Supports GMP building Environmental Monitoring processes and reports.
• Participates in or leads risk assessments for sampling sites in GMP areas.
• Assists change controls, deviations, audit processes; provides support from Environmental Control perspective.
• Participates in forums and meetings to present data-driven actions and recommendations.
• Ensures facilities and processes comply with cGMP and applicable regulations.
• Supports internal/external audits and continuous improvement initiatives.

Skills

Quality Systems

Technical Writing

Documentation management

GMP compliance

IQ/OQ/PQ

Education

Bachelor's in sciences with concentration in any science discipline such as Engineering, Biology, Chemistry, Physics, Computer, etc.

Job description

Quality Consulting Group, LLC is seeking a talented, highly motivated quality professional to join our team in Puerto Rico and the USA, contributing to world-class manufacturing quality and environmental monitoring programs.

You will support deviations, change controls, CAPAs, and validation activities, preparing GMP documentation and reports. Collaboration with cross-functional teams and participation in audits are expected, ensuring compliance with cGMP and applicable regulations.