GMP Quality & Compliance Specialist

Quality Consulting Group, LLC; Juncos (PR); On-site; USD 60,000 - 90,000; Full time

Job summary

Quality Consulting Group, LLC in Puerto Rico and the USA seeks a talented Quality professional to join our team, focusing on cGMP compliance, validation, and quality systems support in manufacturing environments.

You will contribute by handling deviations, change controls, CAPAs, and GMP documentation, perform risk assessments, and assist in internal/external audits and inspections. Strong technical writing and cross-functional collaboration are essential.

Qualifications

• Qualify in Quality Systems with Deviations, Change Controls, CAPAs and GMP documentation.
• Experience in Validation, Commissioning and Qualification (IQ/OQ/PQ) of equipment and lab instruments.
• Strong technical writing for GMP documentation and reports.

Responsibilities

• Supports client site GMP buildings Environmental Monitoring process.
• Generates Environmental Monitoring and Critical Utilities trend reports.
• Leads and participates in risk assessments for sampling sites.
• Assists in change controls, deviations, and audit processes for Environmental Control.
• Represents data in forums and participates in Management Review meetings.
• Ensures compliance with cGMP and applicable regulations.
• Supports internal/external audits and inspections as needed.

Skills

Quality Systems

Deviation management

Change controls

CAPA management

Technical writing

GMP compliance

Education

Bachelor's in sciences

Job description

Quality Consulting Group, LLC in Puerto Rico and the USA seeks a talented Quality professional to join our team, focusing on cGMP compliance, validation, and quality systems support in manufacturing environments.

You will contribute by handling deviations, change controls, CAPAs, and GMP documentation, perform risk assessments, and assist in internal/external audits and inspections. Strong technical writing and cross-functional collaboration are essential.