Senior QA Specialist: Validation & Compliance Expert

QRC Group, Inc; Juncos (PR); On-site; USD 90,000 - 140,000; Full time

Job summary

QRC Group, LLC is seeking a Senior QA Specialist with extensive experience in commissioning and qualification, plus equipment validation and QRAES. The candidate will work within the pharmaceutical, medical device, and chemical sectors to ensure validated lifecycle processes.

The role requires advanced education and significant directly related experience, with a strong emphasis on GxP, GDP, and change controls. This position is based on-site in a regulated environment.

Qualifications

• Advanced degree in a relevant field is required or equivalent experience.
• Experience in commissioning, qualification, and validation activities in pharma/med device.
• Knowledge of regulatory expectations (GDP, GMP) and change controls.

Responsibilities

• Lead commissioning and qualification activities for equipment and systems.
• Perform equipment validation and process validation as applicable.
• Maintain Good Documentation Practices and ensure compliant documentation.
• Support change controls, SOP updates, and quality system improvements.

Skills

Commissioning

Qualification

Equipment Validation

Education

Doctorate + 2 years

Masters + 4 years

Bachelors + 6 years

Associates + 10 years

High school/GED + 12 years

Tools

Kneat

Job description

QRC Group, LLC is seeking a Senior QA Specialist with extensive experience in commissioning and qualification, plus equipment validation and QRAES. The candidate will work within the pharmaceutical, medical device, and chemical sectors to ensure validated lifecycle processes.

The role requires advanced education and significant directly related experience, with a strong emphasis on GxP, GDP, and change controls. This position is based on-site in a regulated environment.