Reagent Fill Technician I
10808 Willow Court San Diego, CA 92127 US
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.
- 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.
- Requires High School Diploma or GED
- 1 year minimum experience in a lab setting.
- Prior experience in a regulated setting preferred.
- 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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