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Reagent Fill Technician IV

San Diego, CA 92127

Posted: 04/18/2024 Employment Type: Contract Job Category: Production Job Number: 601483 Is job remote?: No Country: United States

Job Description


Target PR: 32/hr
*Based on experience

Summary:
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.

Primary Responsibilities:
  • 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. ·
  • 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 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 set-up, change over and operation to ensure completion within the scheduled time frame.
  • Performs device history record review release and collaborates with Quality Assuance on any outstanding issues
  • Propose updates and edit and format documents including device master records and Standard Operating Procedures (SOP) ·
  • Work in cross-functional 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 needs.
  • May mentor and help train Reagent Fill Technicians 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.
Education:
  • Requires Associates Degree in Biology, Mechanics, Engineering or related field.
Experience:
  • 6 years minimum experience as a reagent fill technician or equivalent in a regulated setting. 2 years experience troubleshooting fill equipment. 7 years minimum experience in a lab setting is highly preferred.
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