Reagent Fill Technician Iii

Job Summary:

Dexian is seeking a Reagent Fill Technician III for an opportunity with a client located in San Diego, CA.

Responsibilities:

• 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
• 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 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, 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

Requirements:

• Requires associate degree in biology, Mechanics, Engineering, or related field
• 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
• 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.

Dexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide. As one of the largest IT staffing companies and the 2nd largest minority-owned staffing company in the U.S., Dexian was formed in 2023 through the merger of DISYS and Signature Consultants. Combining the best elements of its core companies, Dexian's platform connects talent, technology, and organizations to produce game-changing results that help everyone achieve their ambitions and goals.

Dexian's brands include Dexian DISYS, Dexian Signature Consultants, Dexian Government Solutions, Dexian Talent Development and Dexian IT Solutions. Visit https://dexian.com/ to learn more.

Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.