Reagent Fill Tech II - TPZ Manufacturing

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.

Grifols Diagnostic Solutions is seeking a Reagent Fill Technician II in San Diego, CA to help support Manufacturing. The Reagent Fill Tech II is responsible for performing manufacturing and assembly of clinical and commercial products. Weighs, measures, and checks raw materials and/or manufacturing parts to assure that batches manufactured contain proper ingredients and quantities. Participates in the filling, aliquoting, and packaging of bulk material into the final product.       

 

To succeed in this opportunity, we are seeking individuals with a High School Diploma and a minimum of 2 years of experience as a reagent fill technician in a regulated setting, with 3 years minimum experience in a lab setting. Knowledge of mechanics or engineering desired.

             

 Primary responsibilities for role:

• Handling and traying of temperature-sensitive (semi-)finished goods for use in blood screening kits
• Perform in-process visual inspection of temperature-sensitive (semi-)finished goods for use in blood screening kits as they come off the fill line before placement in trays.
• Perform sample gathering of temperature-sensitive (semi-)finished goods for use in blood screening kits for QC and Bioburden. 
• Receives and verifies the accuracy of materials transferred from the warehouse. 
• Assists with material handling, folding product boxes/trays and staging of materials for process orders
• Understands and executes written procedures in accordance with cGMP. 
• Performs labor transactions in the Enterprise Resource Planning (ERP) System.                       
• Maintains detailed and accurate device history records with cGMP and forwards them in a timely manner for review.
• General manufacturing area housekeeping including cleaning of labware, equipment, totes, shelves, benches and sinks and removing trash.
• Ensures proper transportation, handling, and disposal of hazardous, bio-hazardous and/or infectious substances.
• Maintains accurate and complete training records.
• Maintains and archives Manufacturing log sheet records.    
• Demonstrate processes during  audits, including ISO, FDA and internal audits.             
• Follows all safety rules. 
• Must be able to communicate product issues, safety incidences and/or personal issues affecting production timelines.
• Independently perform and lead the set-up and operation of reagent filling equipment of at least 33% of automated fill machines.        
• Performs material and labor transactions in the Enterprise Resource Planning (ERP) System.
• Perform basic troubleshooting activities to ensure continued operation of the fill machines.  
• Participate in process improvement projects from inception to completion
• Identify new opportunities for 5S
•  Verify or perform cycle counts and verify discrepancy, conduct investigation and complete report to notify lead

 

Additional Responsibilities:

Cross-functional communication participation. Assists packaging crew as needed. Responsible for flushing water ports and eyewash stations. Adhere to target manufacturing timelines. Punctuality and attendance are required. Attentiveness and openness to learn new processes. Performs refrigerator/freezer maintenance. May cross-train in other areas of manufacturing and operations based on business need. May mentor and help train Reagent Fill Technician I.

 

 

                                                                                               

Knowledge, Skills, and Abilities:

Demonstrated job specific technical knowledge. Working knowledge of laboratory safety and record keeping. Working knowledge of GDP, GMP and ISO Reg. Blood Borne Pathogen Training. Intermediate knowledge of Microsoft Office software. Attention to detail, good organizational skills and team-oriented. Ability to follo