Location: Devens,MA, USA
Note: Candidate must be comfortable with handling patient blood and blood derived drug products as well as liquid nitrogen handling. The incumbent is responsible that all finished goods are packed in accordance to specifications and for completing all packaging documentation required before line start-up and during the packaging process. This position must comply with all Security Guidelines, Environmental Health and Safety regulations and cGMP's. Education: Minimum high school diploma Skills/experience required: 1. Operates equipment, following all established CGMP and Safety regulations. • Set up packaging line. • Prepare packaging along with packaging documentation required. • Packaging of finish goods in accordance to specifications. 2. Performs line clearance and changeovers. 3. Verifies all components against the packaging order. 4. Completes packaging documentation required before line start-up and during the packaging process. 5. Inspects the quality and accuracy of all information printed during the packaging process. 6. Selects samples from lots and delivers them to Q.A. following packaging procedures. 7. Performs statistical inspection to packed product. 8. Maintain good housekeeping through packaging and inbound receipt process. 9. Maintain accountability of components for reconciliation. 10. Disposes waste to be recycling. 11. Substitutes other packaging operators as necessary. 12. Detect discrepancies during the packaging process. 13. Receives in patient incoming blood 14. Processes patient incoming blood for manufacturing 15. Utilizes computer systems such as SAP and MES to perform daily functions - experience no required, will train 16. Gowning required - proper PPE will be worn dditional Job Requirements: Lab w/ blood & animal Position Handles Hazardous Materials