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

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

Additional Responsibilities:

• 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.

Knowledge, Skills and Abilities:

• 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.

Education:

Requires High School Diploma, GED. Associates Degree in Biology, Mechanics, Engineering or related field is preferred.

Experience:

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.
Mechanics certification desired.
At least 4 years of experience with Good Documentation Practices (GDP), Current Good Manufacturing Practices (cGMP) and ISO 13485 Regulations is required.

Occupational Demands:

The physical demands are representative of those that must be met by an employee to successfully perform the essential functions of this job. 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, p+A50:D50ull 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

PayScale

The estimated pay scale for this Reagent Fill & Bulk Technician IV role based in San Diego, California is $33.49 to $41.86 per hour. Additionally, the position is eligible to participate in up to 5% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us!

Pay: $33.49 - $41.86 per hour

Work Location: In person