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Reagent Fill Technician I

San Diego, CA 92127

Posted: 04/01/2024 Employment Type: Contract Job Category: Production Job Number: 601478 Is job remote?: No Country: United States

Job Description


Target PR: 20/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 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 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.
  • Operates basic filling equipment.
  • Maintains and archives Manufacturing log sheet records.
  • Demonstrate processes during audits, including ISO, FDA and internal audits.
  • Participates in sustaining established 5S. \
  • Participates in continuous improvement projects.
  • Performs regular cycle count activities to maintain inventory accuracy.
  • Follows all safety rules.
  • Must be able to communicate product issues, safety incidences and/or personal issues affecting production timelines.
Knowledge, Skills and Abilities:
  • Working knowledge of laboratory safety and record keeping. -Working knowledge of GDP, GMP.
  • Working knowledge of Microsoft Office software. Attention to detail, good organizational skills and team-oriented.
  • Ability to follow oral and written instructions.
Education:
  • Requires High School Diploma or GED
Experience:
  • 1 year minimum experience in a lab setting.
  • Prior experience in a regulated setting preferred.
Occupational Demands:
  • The physical demands are representative of those that must be met by an employee to successfully perform the essential functions of this job.
  • Visually inspect components and final kits for compliance and specifications.
  • Close vision (20 inches or less) will be utilized and some color identification will be required.
  • Frequently required to stand, sit, use hands/fingers to handle or feel, perform reaching, bending, stooping or kneeling motions.
  • Operators may be required to walk for a considerable amount of time.
  • May occasionally lift, carry, push, pull or otherwise manipulate objects up to 40 pounds in weight.
  • Will be required to frequently or continuously lift, carry, push, pull or otherwise manipulate objects up to 10 pounds in weight.
  • May move heavier (greater than 50 pounds) objects and/or materials using carts or pallet jacks.
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