Reagent Fill Technician II - Contract - TalentBurst, Inc.
San Diego, CA
About the Job
Reagent Fill Technician II
Job Duration: 6+ Months
Location: San Diego, CA, 92127
Shift hours: 7:00am-3:30pm PST Mon-Fri
Job description:
Job Duration: 6+ Months
Location: San Diego, CA, 92127
Shift hours: 7:00am-3:30pm PST Mon-Fri
Job description:
- 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.
- -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.
- -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 33% of automated fill machines.
- -Performs material and labor transactions in the Enterprise Resource Planning (ERP) System.
- -Perform basic troubleshooting activities to ensure continued operation of the fill machines.
- -Participate in process improvement projects from inception to completion
- -Identify new opportunities for 5S.
- -Verify or perform cycle counts and verify discrepancy, conduct investigation and complete report to notify lead.
- -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 needs.
- -May mentor and help train Reagent Fill Technician I.
- -Demonstrated job specific technical knowledge.
- -Working knowledge of laboratory safety and record keeping.
- -Working knowledge of GDP, GMP and ISO Reg.
- -Blood Borne Pathogen Training. -Intermediate knowledge of Microsoft Office software.
- -Attention to detail, good organizational skills and team-oriented.
- -Ability to follow oral and written instructions.
- -Basic knowledge of laboratory science, procedures, techniques, instruments & equipment.
Education:
- Requires High School Diploma or GED
- 2 years minimum experience as a reagent fill technician or equivalent in a regulated setting.
- 3 years minimum experience in a lab setting is highly preferred.
- Knowledge of mechanics or engineering desired.
- 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.
Source : TalentBurst, Inc.