Reagent Fill Tech IV

GRIFOLS, S.A.•San Diego, CA

4d•$30 - $38•Onsite

About The Position

Grifols Diagnostic Solutions Inc is seeking a Reagent Fill Technician IV to support Grifols Diagnostic’s Nucleic Acid Testing (NAT) Manufacturing. The Reagent Fill Technician IV 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. To succeed in this role, we are seeking candidates to have at least an Associates Degree in Biology, Mechanics, Engineering or related field. With 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. Individuals with experience in microliters, sealing process (with temperature and time), Vision Systems, familiar with cleaning process (cleaning pumps and operating autoclave washers) are preferred.

Requirements

Requires Associates 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.
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

7 years minimum experience in a lab setting is highly preferred.
Individuals with experience in microliters, sealing process (with temperature and time), Vision Systems, familiar with cleaning process (cleaning pumps and operating autoclave washers) are preferred.

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.
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
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 Technican 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.