Reagent Fill Technician IV

Job Title: Reagent Fill Technician IV
Location: San Diego, CA
Pay rate: $33 - $37.87/hr.
Zip Code: 92101
Area Code: 619
Start Date: Right Away
Keywords: #SanDiegoJobs; #ReagentFillTechnicianJobs;

Benefits:
* Medical / Health Benefits with multiple plan options, Flexible Spending Accounts, Dental and Vision
* 401k
* On the job training / cross-training
* Life Insurance, disability insurance
* Voluntary life insurance for family members available.
* Accident and critical illness insurance optional.
* Scheduled performance reviews
* Referral program

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 Assuance 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

Belcan is an equal opportunity employer. Your application and candidacy will not be considered based on race, color, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other characteristic protected by federal, state or local laws.