Reagent Bulk & Fill Technician IV - Variable Shift - 3rd 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.

Grifols Diagnostic Solutions is seeking a Reagent Bulk & Fill Technician IV in San Diego, CA. There is a variable shift requirement for the position. Responsible for the manufacture of bulk clinical and commercial kit reagents. Responsible for sub-assembly formulation, raw material prep and/or processing, as well as 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 bulking,  filling, aliquoting, and packaging of bulk material into the final product. May be assigned to one or more functional Manufacturing areas. 

 

Candidates must be flexible and willing to work first, second, and third shifts, including weekends, based on production requirements. They must also be willing to adjust planned PTO in accordance with company shutdown schedules and business needs.

Current hiring priority is for the third shift, which operates from 10:00 PM to 6:30 AM. Eligible off-shift schedules may qualify for additional shift differential pay.

 

Responsibilities:

• Backup Lead: Lead Tier meeting, ensure Team utilization is maintained and form filled out, responsible for turning DHR to QA. Communicate with Warehouse, Planners for schedule update/change.
• Cycle count coordinator: distribute and review count sheets, check for discrepancies and assist in discrepancy investigations
• Provide suggestions and feedback for departmental CAPAs: coordinate discussions within the team and cross-functionally.
• Subject matter expert at a minimum of one area of bulk/ Fill process - will interact with Manufacturing Sciences to assist with product transfer and investigations
• Responsible for the staging of raw material and formulation of reagent bulks or constituents, folding trays
• Propose updates and edit and format documents including device master records and Standard Operating Procedures (SOP)
• Support lab walkthrough for audit preparation.
• Handling and traying of temperature-sensitive (semi-)finished goods for use in blood screening kits
• Perform inprocess 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.
• 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.
• Demonstrates processes during  audits, including ISO, FDA and internal audits.
• Follows all safety rules.
• Escalates product issues, safety incidences and/or personal issues affecting production timelines to management.
• Independently perform and lead the set-up and operation of reagent filling equipment of at least 90% of automated fill machines
• Act as mentor and train Reagent Bulk & Fill Technician I, Reagent Bulk & Fill Technician II and Reagent Bulk & Fill  Technician III
• Assist with training and mentoring Reagent Bulk & Fill Te