Biopharma Operations Specialist

hace 2 semanas


Juncos, Puerto Rico Biopharma Consulting Jad Group A tiempo completo

Job Description:

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We are seeking a skilled and proactive Biopharma Operations Specialist to support the execution of manufacturing and quality systems. This role requires minimal supervision and involves supporting process operations, including non-conformance management, process validation, procedural development, training, and new product introductions.

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About this Role:

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The ideal candidate will apply their expertise in bioprocessing unit operations and GMP production workflows, regulatory compliance, and scientific principles to enhance manufacturing processes and ensure adherence to standards.

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Key Responsibilities:

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• Initiate, revise, and approve manufacturing procedures to ensure alignment with current operations

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• Monitor process performance by observing operations and reviewing performance data to identify and implement process improvements

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• Provide troubleshooting support to address operational challenges

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• Assist in the creation of training materials and deliver training on scientific or technical aspects of processes

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Requirements:

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A Doctorate degree OR Master's degree with 3+ years of manufacturing operations experience OR Bachelor's degree with 5+ years of manufacturing operations experience OR Associate's degree with 10+ years of manufacturing operations experience OR High school diploma/GED with 12+ years of manufacturing operations experience.

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PREFERRED QUALIFICATIONS:

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Hands-on experience managing CAPAs in manufacturing settings, Expertise in change control management and project management, Strong background in risk management and documentation of deviations.

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About Us:

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Biopharma Consulting Jad Group is a leading consulting firm dedicated to providing expert services in biopharmaceutical manufacturing and quality assurance.



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