Kelly Science, Engineering, Technology & Telecom ยท 21 hours ago
Quality Assurance Specialist
Kelly Science & Clinical is seeking a Quality Assurance Specialist I for a 12-month contract position at a leading molecular and diagnostics client in Lodi, CA. The Quality Assurance Specialist I is responsible for reviewing records to comply with QSR and ISO requirements, making recommendations for improvement, and creating training materials and operating manuals.
Responsibilities
Collaborating with manufacturing department for scheduling line clearance and line set up activities
Verify line clearance and line set-up activities by signing in relevant sections of documents
Reviewing the batch records online, if necessary
Review records and documents, for completeness and compliance with QSR and ISO requirements
Review batch record to support release of raw materials, work in progress and final products. This includes reagents, components and instrumentation-related products to ensure they are on the right path
Generate standard operating procedures to define and improve quality system functions
Qualification
Required
High school diploma with at least 2 years of work experience in a manufacturing environment
Must be familiar with ISO standards and applicable regulatory requirements (CE/FDA/QSR) and GDP
Ability to interface well with people of varied backgrounds, and to guide groups toward effective dynamics
Must be authorized to work lawfully in the United States for any employer without sponsorship
Preferred
Experience in DNA diagnostics or other medical devices
Company
Kelly Science, Engineering, Technology & Telecom
Kelly Science, Engineering, Technology & Telecom specializes in science, engineering, technology, and telecom.