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Scimed Graphics Inc.

Quality Assurance Specialist for Pharmaceutical Labels & Inserts Printing

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What they do

A Quality Assurance Specialist specializes in the prevention of faults in manufactured products and solutions.

$65,261 / year median in New York

-0% projected decline

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Job Description

Quality Assurance Specialist for Pharmaceutical Labels & Inserts Printing Scimed Graphics Inc. Hauppauge, NY Job Details Full-time From $25 an hour 1 day ago Qualifications Manufacturing facility experience Attention to detail Quality audits Data collection FDA regulations Full Job Description Overview We are seeking a highly motivated and detail-oriented Quality Assurance Specialist to oversee the printing and quality control of pharmaceutical labels and inserts. This vital role ensures that all printed materials meet stringent quality standards, regulatory requirements, and safety guidelines essential for pharmaceutical manufacturing. The ideal candidate will be passionate about maintaining high-quality production processes, ensuring compliance with FDA regulations, GMP standards, and industry best practices. Join our team to contribute to the integrity of pharmaceutical packaging and safeguard patient safety through meticulous quality assurance. Responsibilities Conduct comprehensive quality audits of printed labels and inserts to verify adherence to specified design, content accuracy, and print quality standards. Implement and maintain QA/QC procedures aligned with
GMP, FDA
regulations, and pharmaceutical industry standards to ensure consistent product quality. Establish Standard Operating Procedures (SOPs), amend for changes and create change control procedures wherever required. Perform regular inspections during the printing process, utilizing quality inspection techniques and data collection methods to identify defects or deviations promptly. Ensure compliance with regulatory and legal standards by reviewing print materials for accuracy, completeness, and adherence to labeling regulations. Collaborate with manufacturing teams to monitor production workflows, enforce quality systems, and facilitate continuous improvement initiatives. Utilize Microsoft Office tools for documenting inspection results, audit reports, non-conformance reports, and corrective actions. Enforce the use of personal protective equipment (PPE) during inspections to maintain a safe working environment in accordance with safety protocols. Experience Proven experience in quality assurance or quality control within a manufacturing environment, preferably in pharmaceutical or related industries such as food safety or medical devices. Strong understanding of quality standards in production processes, including GMP (Good Manufacturing Practices), FDA regulations, ASME codes & standards, and other regulatory compliance requirements. Experience in creating standard operating procedures and change control procedures. Experience in maintained detailed documentation wherever required. Demonstrated ability to perform detailed quality inspections and audits using established protocols and analysis skills. Familiarity with manufacturing workflows involving labels, inserts, or packaging materials for pharmaceuticals or similar regulated products. Proficiency in data collection, analysis skills, and reporting using Microsoft Office applications. Knowledge of quality management systems (QMS) and experience implementing or maintaining ISO or equivalent standards is a plus. Join us in ensuring the highest level of quality in pharmaceutical labeling—your expertise will help protect patients worldwide while advancing your career in a dynamic manufacturing environment!
Pay:
From $25.00 per hour
Work Location:
In person