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

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Commissioning & Qualification Specialist is focused on providing technical and documentation support for validation and startup activities within the pharmaceutical industry. The selected candidate will work directly on-site, collaborating with cross-functional teams to ensure compliance with regulatory and operational standards.

Key Responsibilities

• Develop commissioning and/or qualification documentation including URS, FS, IQ/OQ/PQ protocols, and final reports.

• Prepare executed binders, enter qualification data into the designated system, and deliver documentation to the document control area.

• Provide technical information and support related to qualification protocols and documentation to internal teams.

• Offer technical assistance to resources and management throughout the qualification process.

• Maintain effective communication with project sponsors and stakeholders regarding project status, progress, and risks.

• Coordinate with the client and/or end users to ensure tasks are completed with minimal disruption to daily operations and within the established project timeline.

• Actively participate in the review, development, and execution of documentation related to commissioning and qualification activities at the customer site.

• Bachelor degree in Engineering, Life Sciences, or related fields.

• Previous experience in validation, commissioning, or qualification projects in regulated industry.

• Knowledge of documentation best practices and regulatory standards (e.g., GMP, FDA).

• Strong communication, organizational, and teamwork skills.

• Ability to work in dynamic, results-driven environments.

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