Reagent Bulk & Fill Technician IV - Variable Shift - 3rd shift

Grifols•San Diego, CA

8d•Onsite

About The Position

Grifols Diagnostic Solutions is seeking a Reagent Bulk & Fill Technician IV in San Diego, CA. This role is responsible for the manufacture of bulk clinical and commercial kit reagents, including sub-assembly formulation, raw material preparation, and processing. The technician will also perform manufacturing and assembly of clinical and commercial products, weighing, measuring, and checking raw materials to ensure batch accuracy. Key activities include bulking, filling, aliquoting, and packaging of bulk material into the final product. Candidates must be flexible with shifts, including weekends, and willing to adjust PTO according to company schedules. The current hiring priority is for the third shift (10:00 PM - 6:30 AM), which may qualify for additional shift differential pay.

Requirements

High School Diploma, GED.
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.
Visually inspect components and final kits for compliance and specifications.
Close vision (20 inches or less) will be utilized and some color identification will be required.
Frequently required to stand, sit, use hands/fingers to handle or feel, perform reaching, bending, stooping or kneeling motions.
Operators may be required to walk for a considerable amount of time.
May occasionally lift, carry, push, pull or otherwise manipulate objects up to 40 pounds in weight.
Will be required to frequently or continuously lift, carry, push, pull or otherwise manipulate objects up to 10 pounds in weight.
May move heavier (greater than 50 pounds) objects and/or materials using carts or pallet jacks.
Must be able to work evenings and weekends based on production schedules.
Must be able to adjust PTO usage based on production and shutdown schedules.
Must be able to work first, second, and third shifts based on production schedules.
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.

Nice To Haves

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

Responsibilities

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.
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.
Act as a subject matter expert in at least one area of bulk/fill process and interact with Manufacturing Sciences for product transfer and investigations.
Stage raw material and formulate 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.
Handle and tray 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 Bio-burden.
Receive and verify the accuracy of materials transferred from the warehouse.
Assist with material handling, folding product boxes/trays and staging of materials for process orders.
Understand and execute written procedures in accordance with cGMP.
Perform labor transactions in the Enterprise Resource Planning (ERP) System.
Maintain detailed and accurate device history records with cGMP and forward them in a timely manner for review.
Perform general manufacturing area housekeeping including cleaning of labware, equipment, totes, shelves, benches and sinks and removing trash.
Ensure proper transportation, handling, and disposal of hazardous, bio-hazardous and/or infectious substances.
Maintain accurate and complete training records.
Maintain and archive Manufacturing log sheet records.
Demonstrate processes during audits, including ISO, FDA and internal audits.
Follow all safety rules.
Escalate 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.
Serve as the primary contact for material transfer delegation.
Identify new opportunities for 5S.
Conduct Quality notification (QN) investigations: provide information to the quality notification author to complete the quality notification investigation and capable of generating QN/OTR investigations.
Lead equipment troubleshooting during set-up, change over and operation to ensure completion within the scheduled time frame.
Perform device history record review release and collaborate with Quality Assurance on any outstanding issues.
Work in cross-functional teams to lead process improvement projects within the filling department.
Print and distribute cycle count forms, gather and review completed forms, and investigate discrepancies.
Assist with Device History Record (DHR) review.
Proficiently utilize SAP transactions to verify materials, consumption, labor hours, sampling, and material labeling.
Manage training documentation and GTP records, with a focus on accuracy, clarity, and timely updates.
Provide 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 responsibility for quality notification investigations, change controls and documentation updates.
Cross-functional communication participation.
Assist packaging crew as needed.
Responsible for flushing water ports and eyewash stations.
Adhere to target manufacturing timelines.
Perform 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.
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.