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Reagent Filling Technician Iv
3 months ago
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.
Summary:
Grifols Diagnostics Solutions is seeking a Reagent Filling Technician IV in San Diego, CA. This role will report to the Senior Manager, Manufacturing. This position 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.
In order to be successful in this position, we are looking for at least an Associates Degree in Biology, Mechanics, Engineering, or related field along with 6 years of minimum experience as a Reagent Fill Technician.
You must also have 2 years of experience troubleshooting fill equipment and total of 7 years in a lab setting is preferred.
Primary responsibilities for role:
- Handling and traying of temperaturesensitive (semi)finished goods for use in blood screening kits.
- Perform inprocess visual inspection of temperaturesensitive (semi)finished goods for use in blood screening kits as they come off the fill line before placement in trays.
- Perform sample gathering of temperaturesensitive (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, biohazardous 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 setup and operation of reagent filling equipment of at least 90% of automated fill machines.
- Primary contact for material transfer delegation.
- Implement new areas or ideas for 5S.
- Quality notification (QN) investigations: provide information to the quality notification author to complete the quality notification investigation.
- Act as mentor and train Reagent Fill Technician I, Reagent Fill Technician II and Reagent Fill Technician III.
- Lead equipment troubleshooting during the setup, change over and operation to ensure completion within the scheduled time frame.
- Performs device history record review release and collaborates with Quality Assurance on any outstanding issues.
- Propose updates and edit and format documents including device master records and Standard Operating Procedures (SOP).
- Work in crossfunctional teams to lead process improvement projects within the filling department.
- Responsible for printing and distributing the cycle count forms, gathering and reviewing the completed forms, and investigating discrepancies.
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, II and III. Assist with Device History Record (DHR) review. May be responsible for demonstrating manufacturing processes during a customer or regulatory audit. Initiate Quality Notifications (QN). Act as rework coordinator. Initiate lab walkthrough for audit preparation.
Knowledge, Skills, and Abilities:
Demonstrated job specific technical knowledge. Advanced knowledge of laboratory safety and record keeping. Intermediate knowledge of GDP, GMP and ISO Reg. Blood Borne Pathogen Training. Advanced knowledge of Microsoft Office software. Attention to detail, good organizational ski
