Reagent Fill Technician III - Variable Shift - 3rd shift

Grifols•San Diego, CA

8d•Onsite

About The Position

Grifols Diagnostic Solutions Inc is seeking a Reagent Fill Technician III to support Grifols Diagnostic’s Blood Typing Solutions Manufacturing. The Reagent Fill Technician III will be 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.

Requirements

At least a High School Diploma, GED or Associates Degree in Biology, Mechanics, Engineering or related field.
4 years minimum experience as a reagent fill technician or equivalent in a regulated setting.
Prior experience troubleshooting fill equipment.
Demonstrated job specific technical knowledge.
Intermediate knowledge of laboratory safety and record keeping.
Working knowledge of GDP, GMP and ISO Reg.
Blood Borne Pathogen Training.
Advanced knowledge of Microsoft Office software.
Attention to detail, good organizational skills and team oriented.
Ability to follow oral and written instructions.
Intermediate knowledge of laboratory science, procedures, techniques, instruments & equipment.
Ability to effectively communicate with team members and cross-functional departments.

Nice To Haves

4-5 years minimum experience in a lab setting is highly preferred.
Mechanics certification desired.

Responsibilities

Handling and traying of temperature-sensitive (semi-)finished goods for use in blood typing kits
Perform in process visual inspection of temperature-sensitive (semi-)finished goods for use in blood typing 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 typing 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
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 need.
May mentor and help train Reagent Fill Technician I and II.
Assist with Device History Record (DHR) review.
May be responsible for demonstrating manufacturing processes during a customer or regulatory audit.