Validation Specialist

Company Description

QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.

Log on now to our website http://www.qrcgroup.com/ to learn more about our services and solutions!

Job Description

Validation Specialist with hands-on experience in executing validation and qualification activities across diverse areas, including:

• Process
• Packaging
• Manufacturing
• Laboratory
• Computer System Validation (CSV)
• Software
• Facilities and Utilities
• Site Acceptance Testing (SAT) & Factory Acceptance Testing (FAT)
• Commissioning and Decommissioning of Systems and Equipment

Core Competencies:

• Skilled in drafting protocols, technical reports, and validation documentation in alignment with regulatory and industry standards (e.g., FDA, GMP).
• Proven ability to collaborate effectively with cross-functional teams—including Engineering, Quality, and Production—to ensure compliance, optimize processes, and support operational readiness.

Qualifications

• Bachelor Degree in Science, or related field
• Minimum 5 years of experience in validations within a regulated industry.
• In-depth knowledge of GMP, FDA, and international standards.
• Hands-on experience in IQ/OQ/PQ, SAT/FAT, and commissioning.
• Ability to write clear and precise technical documentation.
• Excellent communication and teamwork skills.
• Bilingual (English/Spanish - understand, write and speak).

Additional Information

All your information will be kept confidential according to EEO guidelines.