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Quality Systems Specialist

On-site Contract

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Experience Level

Experience

Qualifications

To be successful in this role, candidates should have:2-3 years of experience in a regulated cGMP environment. Prior experience in the pharmaceutical or biotech sector is preferred. A strong combination of experience in Quality Assurance with knowledge of Facilities/Utilities design, maintenance, and validation. Proficiency in Excel, PowerPoint, Maximo, and TrackWise software.

About the job

The Quality Systems Specialist will play a crucial role in ensuring compliance and excellence within a regulated cGMP environment. The ideal candidate will possess 2-3 years of experience in the pharmaceutical or biotech industry, with a robust background in Quality Assurance and a solid understanding of Facilities and Utilities design, maintenance, and validation.

Key responsibilities include the development and generation of detailed QA metrics, including validation document turnaround times, Quality System record processing, and overall group performance data. You will be responsible for conducting first-line reviews of Maximo work orders and job plans, ensuring compliance with GMP standards for calibration and maintenance of essential utility systems such as HVAC and purified water systems.

Additionally, the specialist will review operational procedures as a quality assurance representative, ensuring adherence to GMP-compliant standard operational procedures. Quality reviews of validation lifecycle documents will also be a key part of the role, including system impact assessments and validation protocols.

Support for Quality Systems activities, including Deviations, Change Controls, and CAPA records, is essential. Familiarity with TrackWise software and involvement in quality system investigations and corrective action projects will be required.

About Integrated Resources, Inc.

Integrated Resources, Inc. is a leading provider of innovative solutions in the biotech and pharmaceutical sectors, dedicated to ensuring safety, quality, and compliance in every project.

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