Reagent Fill Technician III
Posted on :
24-02-2024
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1 Vacancy
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Job Description
Req ID : 2569809
Job Title: Reagent Fill Technician III
Duration: 6 Month with the possibility of extension
Work Location: San Diego CA 92127
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 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.
- Verify or perform cycle counts and verify discrepancy conduct investigation and complete report to notify lead
- Independently perform and lead the setup and operation of reagent filling equipment of at least 70% of automated fill machines
- Perform equipment troubleshooting during operation to ensure completion within the scheduled time frame
- Assist with training and mentoring Reagent Fill Technicians I and Reagent Fill Technicians II
- Primary contact for material transfer delegation
- Participate in the execution of process improvement projects Implement new areas or ideas for 5S
- Quality notification (QN) investigations: provide information to the quality notification author to complete the quality notification investigation.
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.
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. The applicant must be flexible and willing to work evenings and weekends based on the production schedule needs.
Employment Type
Full Time
Key Skills
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