Omrix Biopharmaceuticals is seeking a Labeling Quality Engineer, for our Tel-HaShomer site.
Reports to Quality system manager.
Provides overall quality assurance support to packaging and labeling of Omrix products and supporting processes.
Implementation of procedures, process, audits, corrective actions.
Duties & Responsibilities
Under and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
Implements changes on secondary packaging materials per local government regulations and company procedures
Utilizes industry and process excellence standards in routine quality operations, including good manufacturing practices (GMP) and international organization for standardization (ISO).
Supports the quality aspects of product and process deviations, including Risk assessments, root cause investigations and preventive / corrective actions.
Supports other operational departments with relevant business needs: Supply chain, Packaging, Engineering, Supplier Quality, and Quality Control.
Reviews processes, including both quality processes and packaging processes. Identifies steps critical to quality and estimates process capability, where applicable. Performs quality system actions in relevant applications (ETQ, Windchill for Change control, CAPA etc.)
Supports site audits.
Leads or participates in continuous improvement projects to implement change within Operations.
Reviews and approves procedures, documents, protocols, reports, and CR.
Reviews and approves artworks.
Reviews and approves URSs.
Participates in teams introducing new products/ processes to the facility, defining the controls and quality standards for new products.
Verifies that quality agreements are in place with the suppliers, contractors and affiliates
Perform other duties assigned as needed