Reagent Fill Tech II - TFZ Manufacturing

Grifols•San Diego, CA

2d•Onsite

About The Position

Grifols Diagnostic Solutions is seeking a Reagent Fill Technician II in San Diego, CA to help support Manufacturing. The Reagent Fill Tech II is 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

High School Diploma or GED
2 years minimum experience as a reagent fill technician or equivalent in a regulated setting.
3 years minimum experience in a lab setting is highly preferred.
Demonstrated job specific technical knowledge.
Working knowledge of laboratory safety and record keeping.
Working knowledge of GDP, GMP and ISO Reg.
Blood Borne Pathogen Training.
Intermediate knowledge of Microsoft Office software.
Attention to detail, good organizational skills and team-oriented.
Ability to follow oral and written instructions.
Basic knowledge of laboratory science, procedures, techniques, instruments & equipment.

Nice To Haves

Knowledge of mechanics or engineering desired.

Responsibilities

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.
Mainains 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 33% of automated fill machines.
Performs material and labor transactions in the Enterprise Resource Planning (ERP) System.
Perform basic troubleshooting activities to ensure continued operation of the fill machines.
Participate in process improvement projects from inception to completion
Identify new opportunities for 5S
Verify or perform cycle counts and verify discrepancy, conduct investigation and complete report to notify lead
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.