Team Lead, Manufacturing TPZ

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 in San Diego, CA is seeking a Team Lead, Manufacturing to support TPZ manufacturing. The Team Lead role will lead and participate in manufacturing run activities including all applicable pre-production and post-production tasks required to support the full process.  This position will also lead and guide manufacturing associates as necessary.        

To succeed in this role, we are seeking individuals with a minimum of BS/BA in one of the biological or physical sciences with a minimum of 6 years’ experience in the biotechnology / medical devices industry and a minimum of 5 years working in a regulated environment, including 3+ years of supervisory or team leadership experience.

Responsibilities

• Responsible for all lab-related activities and area production schedule.
• Guide and lead the work of department associates executing daily operations                          
• Act as a point of contact for the production of an assigned run from start to finish.
• Assign production support activities to other associates in accordance with the schedule.
• Ensure that all production operations are conducted in full compliance with Grifols policies, regulatory (GMP, FDA, ISO) and safety requirements.
• Directly participates in Bulking and Filling activities 41% of the time: material handling, folding product boxes/trays and staging of materials for process orders
• Operates and calibrates as needed all general lab equipment.              
• Maintains, measures and dispenses materials for completion of Bulk formulation activities
• Perform process troubleshooting on instruments and equipment used in bulking/Filling processes
• 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 Bio-burden.
• Receives and verifies the accuracy of materials transferred from the warehouse
• Performs labor and material transactions in the Enterprise Resource Planning (ERP) System.
• Maintains detailed and accurate device history records with cGMP and complete review and corrections in a timely manner.
• Ensure proper handling of biohazardous or infectious substances
• Ensure proper waste disposal and cleaning of facility according to SOP
• General manufacturing area housekeeping including cleaning of labware, equipment, totes, shelves, benches and sinks and removing trash.
• May be working on processes and observed during audits, including ISO, FDA and internal audits.
• Maintains and archives Manufacturing log sheet records.      
• Oversee and document Change over cleaning
• Coordinate and execute applicable analytical testing activities
• Review, initiate, and approve change requests for the department.    
• Initiate production related deviations in the associated quality system
• Manage assigned investigations as required including the implementation of corrective actions.