Quality Assurance Specialist
This is an exciting opportunity to contribute to the development and implementation of quality control procedures in a dynamic environment.
* Main Responsibilities:
* Provide technical assistance during new product launches, ensuring adherence to regulatory requirements such as FDA, QSR, and MDD.
* Apply quality engineering tools and techniques, including validation protocols (DQ, IQ, OQ, PQ), cGMP, PFMEA, and DMF generation.
* Utilize process improvement methodologies and capability analysis to deliver defect-free processes.
* Support sterilization, automation, and equipment/software validation efforts.
* Work in controlled manufacturing environments, adhering to GMP standards.
* Participate in internal and external Quality Management System audits.
* Contribute to CAPA system development and drive quality initiatives across departments.
* Maintain compliance with company policies and safety programs.
* Lead root cause problem-solving efforts in team settings.
* Align customer specifications with operational capabilities.
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Requirements:
* Strong understanding of quality control principles and regulatory requirements.
* Excellent communication and problem-solving skills.
* Ability to work effectively in a team environment.
* Familiarity with quality engineering tools and techniques.
* Knowledge of cGMP and other relevant regulations.
* Basic computer skills and proficiency in Microsoft Office applications.
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What We Offer:
* A collaborative and dynamic work environment.
* Opportunities for professional growth and development.
* A comprehensive benefits package.
* A competitive salary and bonus structure.