QA Associate/Diagnostics

Responsibilities: Kforce is currently recruiting for a QA Associate to work within a growing Invitro Diagnostic company located in northern Orange County. The successful candidate will support the company's quality system by maintaining lot number, inquiry, deviation and non-conforming material databases, labeling (product label and package insert), inspections, file accountability, archiving, review and maintenance of product history records and maintenance of master document file rooms, scanning, and retrieval of controlled records. More specifically, duties include: Inspect and verify product labels and inserts. Perform document and data review for material, intermediate, component, and kit releases. Review and approve device history records, perform raw material inspection, labeling, and release. Perform label reconciliations from DHR and label request forms. Complete release documentation such as release forms and status labels. Conduct review for compliance to and complete documentation within GxP requirements such as GDPs and GMPs. Notify Production and Quality Control of document deficiencies and working with the departments to bring the documentation in compliance. Maintain controlled procedures and forms related to final and intermediate product documentation review and release. Perform and maintain systems for process monitoring. Initiate document change requests to update documents as appropriate. Initiate non-conforming material reports to document material, component and product non-conformances as appropriate. Initiate deviation forms to document manufacturing process changes as appropriate. Initiate and review Certificate of Analysis and Certificate of Conformance forms. Assist with DHR archiving, filing, and scanning. This role typically interfaces with multiple levels within organization.If you are not a local candidate but are relocating, please inform me of your arrangements (i.e., date and city/state you are relocating to).Kforce (NASDAQ: KFRC) is a full-service specialty staffing firm providing flexible and permanent staffing solutions for organizations and career management for individuals in the specialty skill areas of information technology, finance & accounting, human resources, engineering, pharmaceutical, health care and scientific. Backed by more than 1,500 recruiting specialists, Kforce operates in more than 40 markets in North America. For more information, please visit our web site at