Monroe Township, New Jersey, United States
About the Job Quality Assurance Specialist
Key Responsibilities - Support daily QA operations related to document control, change control, training, and CAPA management. - Review and approve production records, quality documentation, and deviations in compliance with internal procedures. - Assist with internal and external audits by preparing records, reports, and responses to findings. - Maintain and update Standard Operating Procedures (SOPs) and ensure proper document archiving and version control. - Coordinate and track employee training to ensure compliance with quality and regulatory requirements. - Support nonconformance and complaint investigations, assisting in root cause analysis and corrective actions. - Collaborate with QC, Production, and Regulatory teams to ensure cross-functional compliance and communication. - Monitor quality metrics and support continuous improvement initiatives within the Quality Management System. - Communicate effectively in both English and Korean across teams and departments.
Qualifications - Bachelors degree in a scientific, engineering, or related field. - 05 years of experience in Quality Assurance or Quality Systems within a GMP or ISO 13485regulated environment. - Experience in medical device, pharmaceutical, or diagnostics industry preferred. - Bilingual in English and Korean preferred - Knowledge of ISO 13485, FDA QSR, and GMP regulations preferred. - Strong attention to detail and documentation accuracy. - Good understanding of quality processes and regulatory principles. - Ability to manage multiple priorities and meet deadlines. - Excellent interpersonal and written communication skills. - Proficiency in Microsoft Office Suite (Word, Excel, Outlook). - Team-oriented mindset with strong problem-solving skills.
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