Reagent Fill Technician III

Reagent Fill Technician III

Location: CA-San Diego, US Contract Type: Regular Full-Time Area: MANUFACTURING

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Grifols Diagnostic Solutions Inc is seeking a Reagent Fill Technician III to support Grifols Diagnostic's Blood Typing Solutions Manufacturing.

The Reagent Fill Technician III 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 a High School Diploma, GED or Associates Degree in Biology, Mechanics, Engineering or related field. Along with 4 years minimum experience as a reagent fill technician or equivalent in a regulated setting. 4-5 years minimum experience in a lab setting is highly preferred. Prior experience troubleshooting fill equipment. Mechanics certification desired.

Shift Requirement: Variable Shift

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.
• Demonstrates 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.
• Verify or perform cycle counts and verify discrepancy, conduct investigation, and complete report to notify lead
• Independently perform and lead the set-up and operation of reagent filling equipment of at least 70% of automated fill machines
• Perform equipment troubleshooting during operation to ensure completion within the scheduled time frame
• Assist with training and mentoring Reagent Fill Technicians I and Reagent Fill Technicians II
• Primary contact for material transfer delegation
• Participate in the execution of process improvement projects
• Implement new areas or ideas for 5S.
• Quality notification (QN) investigations: provide information to the quality notification author to complete the quality notification investigation

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 Fill Technician I and II. Assist with Device History Record (DHR) review. May be responsible for demonstrating manufacturing processes during a customer or regulatory audit.

Knowledge, Skills, and Abilities 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.

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

Experience: 4 years minimum experience as a reagent fill technician or equivalent in a regulated setting. 4-5 years minimum experience in a lab setting is highly preferred. Prior experience troubleshooting fill equipment. Mechanics certification desired.

Equivalency Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements.

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, 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. The applicant must be flexible and willing to work evenings and weekends based on the production schedule needs.

The estimated pay scale for Reagent Bulk & Fill Technician IV role based in 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, life insurance, PTO, paid holidays and 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!