Reagent Fill Technician IV
Posted on :
24-02-2024
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1 Vacancy
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Job Description
Job Title: Reagent Fill Technician IV
Duration: 6 Month with the possibility of extension
Work Location: San Diego CA 92127
Job Description
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 in process 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. 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 Assuance on any outstanding issues
- Propose updates and edit and format documents including device master records and Standard Operating Procedures (SOP)
- Work in crossfunctional 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:
- Crossfunctional 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 crosstrain 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.
Employment Type
Full Time
Key Skills
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