Reagent Bulk & Fill Technician IV - 1st shift - Variable Shift

GRIFOLS, S.A.•San Diego, CA

1d•$33 - $42•Onsite

About The Position

Grifols Diagnostic Solutions is seeking a Reagent Bulk & Fill Technician IV in San Diego, CA. There is a variable shift requirement for the position. Responsible for the manufacture of bulk clinical and commercial kit reagents. Responsible for sub-assembly formulation, raw material prep and/or processing, as well as 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 bulking, filling, aliquoting, and packaging of bulk material into the final product. May be assigned to one or more functional Manufacturing areas. The applicant must be flexible and willing to work first, second, and third shifts, including weekends, based on production schedule needs. The applicant must be flexible in adjusting PTO according to shutdown schedules and production needs.

Requirements

Demonstrated job specific technical knowledge.
Advanced knowledge of laboratory safety and record keeping.
Intermediate 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.
Advanced knowledge of laboratory science, procedures, techniques, instruments & equipment.
Effective communication with cross-functional teams.
Demonstrated ability to work with members of other departments.
Requires High School Diploma, GED. Associates Degree in Biology, Mechanics, Engineering or related field is preferred.
6 years minimum experience as a reagent fill technician or equivalent in a regulated setting.
2 years experience troubleshooting fill equipment.
At least 4 years of experience with Good Documentation Practices (GDP), Current Good Manufacturing Practices (cGMP) and ISO 13485 Regulations is required.

Nice To Haves

7 years minimum experience in a lab setting is highly preferred.
Mechanics certification desired.
Associates Degree in Biology, Mechanics, Engineering or related field is preferred.

Responsibilities

Backup Lead: Lead Tier meeting, ensure Team utilization is maintained and form filled out, responsible for turning DHR to QA. Communicate with Warehouse, Planners for schedule update/change.
Cycle count coordinator: distribute and review count sheets, check for discrepancies and assist in discrepancy investigations
Provide suggestions and feedback for departmental CAPAs: coordinate discussions within the team and cross-functionally.
Subject matter expert at a minimum of one area of bulk/ Fill process - will interact with Manufacturing Sciences to assist with product transfer and investigations
Responsible for the staging of raw material and formulation of reagent bulks or constituents, folding trays
Propose updates and edit and format documents including device master records and Standard Operating Procedures (SOP)
Support lab walkthrough for audit preparation.
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.
Demonstrates processes during audits, including ISO, FDA and internal audits.
Follows all safety rules.
Escalates product issues, safety incidences and/or personal issues affecting production timelines to management.
Independently perform and lead the set-up and operation of reagent filling equipment of at least 90% of automated fill machines
Act as mentor and train Reagent Bulk & Fill Technician I, Reagent Bulk & Fill Technician II and Reagent Bulk & Fill Technician III
Assist with training and mentoring Reagent Bulk & Fill Technician I and Reagent Bulk & Fill Technicians II
Primary contact for material transfer delegation
Identify new opportunities for 5S
Quality notification (QN) investigations: provide information to the quality notification author to complete the quality notification investigation and capable of Generate QN/OTR investigations.
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
Assist with Device History Record (DHR) review.
Proficient in utilizing SAP transactions to verify materials, consumption, labor hours, sampling, and material labelling.
Manages training documentation and GTP records, with a focus on accuracy, clarity, and timely updates
Provides support for other Reagent Bulk & Fill Technician responsibilities and tasks when necessary
Document and report key performance indicators (KPIs) at the end of each shift to ensure visibility and alignment across teams.
Participate in or take responsible for quality notification investigations, change controls and documentation updates
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 Bulk & Fill Technician 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.