Quality Assurance Specialist I

Overview Seeking a Quality Assurance Specialist I to support product quality, process improvements, and quality system programs within a manufacturing environment. This role involves reviewing production records, conducting audits, and ensuring compliance with quality standards. Key Responsibilities Review production batch records (DHRs) for accuracy and completeness Approve intermediate and finished products for release Identify, document, and resolve deviations in production records Perform spot-check inspections and audits of production operations Develop and maintain Standard Operating Procedures (SOPs) Assist in testing complaint and stability samples; report out-of-spec results Initiate and track Quality Incidents (QI) and CAPA activities Manage or assist with sample retention and stability programs Provide backup support to other quality team members Required Qualifications Bachelor’s degree in Chemistry, Biology, Life Sciences, or related technical field 1+ year of experience in Quality Assurance or manufacturing support Preferred Qualifications Experience in Quality Assurance within the medical device or regulated industry Strong attention to detail and documentation accuracy Ability to follow and interpret procedures, manuals, and instructions Familiarity with quality systems, CAPA, and deviation handling Proficiency in MS Excel and Word Strong analytical and problem-solving skills Ability to write reports and communicate effectively Basic mathematical and data interpretation skills #J-18808-Ljbffr Intellectt Inc