Reagent Bulk & Fill Technical Specialist - Shift

Location:

CA-San Diego, US

Contract Type:
Regular Full-Time

Area: 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 Bulk & Fill Technical Specialist. The Reagent Bulk & Fill Technical Specialist is responsible for the manufacture of bulk and fill clinical and commercial kit reagents, including sub-assembly formulation, raw material preparation, and processing. Perform manufacturing and assembly tasks for both clinical and commercial products. Accurately weigh, measure, and verify raw materials and manufacturing components to ensure proper batch composition.

Participate in bulking, filling, aliquoting, cleaning and packaging of bulk materials into final product formats. Assigned to multiple functional areas within Manufacturing to support operational flexibility and cross-training.

Responsibilities

• Backup Team Lead and Supervisor Responsibilities:
  Serve as Backup Team Lead and Supervisor by leading Tier meetings, ensuring team utilization is optimized and documentation forms are completed. Responsible for submitting Device History Records (DHR) to Quality Assurance (QA). Communicate with Warehouse and Planners to manage schedule updates or changes. Document and report key performance indicators (KPIs) at the end of each shift to support operational transparency and performance tracking
• Lead Filling Process Troubleshooting and Equipment Operation:
  Lead troubleshooting efforts within the filling process and elevate issues to the appropriate departments to ensure timely resolution. Independently performance and oversee the setup and operation of reagent filling equipment, including automated fill machines.
• Lead and compile all improvements across the manufacturing lines, aligning with MTS to ensure that critical and high - risk initiatives are executed on time.
• Subject Matter Expert in Bulk and Fill Processes:
  Serve as the technical lead across all areas of bulk and fill operations. Collaborate with Manufacturing Sciences to support product transfers and lead or assist in technical investigation.
• Lead Document Updates and Formatting:
  Oversee the revision, editing, and formatting of controlled documents, including Device Master Records and Standard Operating Procedures (SOPs), ensuring clarity, compliance, and consistency.
• Cycle count specialist and coordinator:
  Distribute and review count sheets, verify inventory accuracy, identify discrepancies, and lead investigations to resolve them.
• Lead Lab Walkthroughs for Audit Preparation:
  Coordinate and conduct laboratory walkthroughs to ensure readiness for audits, verifying compliance, documentation accuracy, and operational standards.
• Leading the handling of finished goods for use in blood screening kits. Perform inprocess visual inspection of finished goods for use in blood screening kits as they come off the fill line. Perform sample gathering of semi-finished goods for use in blood screening kits for QC and Bio-burden.
• Lead Material Handling and Staging
  
  Activities:
  
  Oversee material handling tasks, including folding product boxes and trays, and staging materials for process orders. Receive and verify the accuracy of materials transferred from the warehouse to ensure readiness and compliance.
• Ensure Compliance with cGMP Procedures Understand and execute written procedures in accordance with current Good Manufacturing Practices (cGMP), and ensure team adherence through guidance, oversight, and support. Maintains detailed and accurate device history records with cGMP and forwards them in a timely manner for review. Maintains accurate and complete training records. Maintains and archives Manufacturing log sheet records. Demonstrates proficiency in managing training documentation and GTP records, with a focus on accuracy, clarity, and timely updates.
  
  Performs notebook, development, pilots, validation and commercial builds per GMP guidelines for reagents/sub-assemblies builds.
• Escalate Issues and Ensure Safety Compliance:
  Promptly escalation product-related concerns,…