["Quality Assurance Specialist I","Quality Assurance Specialist I"]

OverviewSeeking 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 ResponsibilitiesReview production batch records (DHRs) for accuracy and completenessApprove intermediate and finished products for releaseIdentify, document, and resolve deviations in production recordsPerform spot-check inspections and audits of production operationsDevelop and maintain Standard Operating Procedures (SOPs)Assist in testing complaint and stability samples; report out-of-spec resultsInitiate and track Quality Incidents (QI) and CAPA activitiesManage or assist with sample retention and stability programsProvide backup support to other quality team membersRequired QualificationsBachelor's degree in Chemistry, Biology, Life Sciences, or related technical field1+ year of experience in Quality Assurance or manufacturing supportPreferred QualificationsExperience in Quality Assurance within the medical device or regulated industryStrong attention to detail and documentation accuracyAbility to follow and interpret procedures, manuals, and instructionsFamiliarity with quality systems, CAPA, and deviation handlingProficiency in MS Excel and WordStrong analytical and problem-solving skillsAbility to write reports and communicate effectivelyBasic mathematical and data interpretation skills#J-18808-Ljbffr