Reagent Fill Technician IV - Contract

TalentBurst, Inc.

San Diego, CA

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JOB DETAILS

SALARY

$33–$37.87 Per Hour

SKILLS

Communication Skills, Cross-Functional, Current Good Manufacturing Practice (cGMP), Documentation Format, ERP (Enterprise Resource Planning), FDA (Food and Drug Administration), Hazardous Materials/Substances, Housekeeping/Cleaning, ISO (International Organization for Standardization), Identify Issues, Internal Audit, Inventory Cycle Counts, Labware, Manufacturing, Manufacturing Assembly, Manufacturing Operations, Manufacturing/Industrial Processes, Medical Products, Mentoring, Order Processing, Organizational Skills, Printing, Process Improvement, Product Safety, Quality Assurance, Quality Control, Regulations, Standard Operating Procedures (SOP), Team Lead/Manager, Time Management, Warehousing

LOCATION

San Diego, CA

POSTED

4 days ago

Title: Reagent Fill Technician IV
Location: San Diego, CA
Duration: 6+ Months
Shift Timings: Mon 7:00 AM 3:30 PM Tue 7:00 AM 3:30 PM Wed 7:00 AM 3:30 PM Thur 7:00 AM 3:30 PM Fri 7:00 AM 3:30 PM

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 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.
Independently perform and lead the set-up 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 set-up, change over and operation to ensure completion within the scheduled time frame.
Performs device history record review release and collaborates with Quality Assurance on any outstanding issues
Propose updates and edit and format documents including device master records and Standard Operating Procedures (SOP)
Work in cross-functional 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:

Cross-functional 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 cross-train 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.

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About the Company

TalentBurst, Inc.

For over 20 years, TalentBurst Inc. has been an award-winning provider of cutting-edge Workforce Management Solutions. With a strong commitment to staying ahead in the tech landscape, we pioneer innovative approaches to talent acquisition. Our expertise spans Life Sciences, and Healthcare Staffing, Banking, Financial, IT, and Engineering, as well as Global Employer of Record (EOR), Agent of Record (AOR), State, Local Government and Education (SLED), and IC validation/compliance services. Additionally, our division, TalentProcure, leads the industry with offerings such as High Hazard Payroll, Managed Services, and Vendor on Premise (VOP) solutions.

Due to our prioritization of excellent standards, we are Joint Commission Certified and are a certified Minority Business Enterprise (MBE) in the USA and Canada. Supporting over 130 Fortune 500 companies globally, we excel in navigating the landscape of talent acquisition. In a world of constant change, we embrace developing people-centric solutions that address the unique demands of our clients. Stay connected by visiting our website and following us on social media!

COMPANY SIZE

5,000 to 9,999 employees

INDUSTRY

Staffing/Employment Agencies

FOUNDED

2002

WEBSITE

http://www.talentburst.com/