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Reagent Fill Technician IV

ICONMA, LLC

San Diego, CA

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JOB DETAILS
SALARY
$33–$37.87 Per Hour
SKILLS
Biotech and Pharmaceutical, Communication Skills, Cross-Functional, Current Good Manufacturing Practice (cGMP), Documentation Format, ERP (Enterprise Resource Planning), FDA (Food and Drug Administration), Health Plan, Housekeeping/Cleaning, ISO (International Organization for Standardization), Identify Issues, Internal Audit, Inventory Cycle Counts, Labware, Manufacturing, Manufacturing Assembly, Manufacturing Operations, Manufacturing/Industrial Processes, Medical Products, Mentoring, Order Processing, Organizational Skills, Printing, Process Improvement, Product Safety, Quality Assurance, Quality Control, Regulations, Standard Operating Procedures (SOP), Team Player, Time Management, Warehousing
LOCATION
San Diego, CA
POSTED
5 days ago
Our client, a Pharmaceutical company, is looking for a Reagent Fill Technician IV for their San Diego, CA location.
 
Responsibilities:
  • 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.
  • 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 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 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
  • 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.
 
Why Should You Apply?  
 

About the Company

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ICONMA, LLC