Plasma Classification Associate / Certified Inspector (1st Shift)

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Plasma Classification Associate Inspector

 

M-F 5:00 am – 1:30 pm

 

Summary:     

                                               

This position requires scanning of Source Plasma units and removal of unsuitable units utilizing the  Plasma Management System (SGP). Functions are performed according to specific Standard Operating Procedures, quality, and safety standards and insuring accuracy.  A visual inspection of plasma units is also performed, to remove any units which are unacceptable for further manufacturing (e.g. damaged, broken port/tube, RBC, or removal rejections). Throughput Standards and Schedule Targets should be met consistently.      

 

Experience:

 

1. One year experience in Manufacturing, Pharmaceutical or other FDA licensed Industry is desirable.
2. Experience working with cGMPs and Industry Standards desirable
3. Experience in reading, understanding, and following Standard Operating Procedures desirable

                                               

 

Primary Responsibilities:

                                                           

1.  Responsible for scanning and inventorying of plasma units assigned to a production unit (PU) utilizing a barcode reader.                                                          

2.  Responsible for identifying and removing units according to various rejection criteria found during visual inspection.                                                      

3.  Responsible for removal of unsuitable plasma units marked for removal in SGP during the PU process.                                                           

4   Responsible for identifying and blocking units from further production when units fail to meet customer requirements.                                                  

5,  Responsible for identifying unreleased units and transferring those units into sub shipments during the PU process.                                                          

6.  Responsible for verification of sub-shipment identification and location at the end of the PU process.                                                

7.  Print/reprint labels as necessary utilizing SGP                                                    

8.  Responsible for identifying and entering abnormalities into SGP via the “Statistics” function, during or after the PU process.                                                  

9.  Responsible for clearing the production line of all material processed in a completed PU before starting the next PU process.                                                        

10.  Responsible for ensuring plasma does not exceed the allowable time out of freezer during production, utilizing the SGP warning system.                                                    

11.  Responsible for scanning of archive samples vials assigned to a Sample Archive (SA) utilizing a barcode reader.                                                

12.  Responsible for completing the partial PU cases between PUs                                                 

13.  Responsible for maintaining cGMP compliance by ensuring a high level of cleanliness and organization.                                                           

14,  Required to interpret and follow written procedures.                                                     

15.  Must maintain record accountability and demonstrate accuracy.                                                          

16.  Job duties should be performed with minimal supervision while consistently meeting department throughput standards.                                                

17.  Ability to cross train in the Material Handling department to ensure efficient plasma operations. 

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