Reagent Fill Technician III

Job Title- Reagent Fill Technician III

Location- San Diego, CA

Duration- 6 Months

Shift: 7:00am-3:30pm, M-F

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 inprocess 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.

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 set-up 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.