Category: Scientific

Employment Type: Contract

Reference: BH-370886

Reagent Fill Technician lV needed for a contract opportunity with Yoh Scientific's client in San Diego, CA.

Pay Rate:$35.77/hour

Contract Length: 6+ months

Schedule: M-F 7am-3:30pm

Summary: 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.

Key Responsibilities:

• Handling and traying of 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 Bioburden.
• 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.
• Ensures proper transportation, handling, and disposal of hazardous, bio-hazardous and/or infectious substances.
• 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.
• 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.
• Quality notification (QN) investigations: provide information to the quality notification author to complete the quality notification investigation.

• 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 Technicians I, II and III.
• Assist with Device History Record (DHR) review.
• May be responsible for demonstrating manufacturing processes during a customer or regulatory audit.
• Act as rework coordinator.
• Initiate lab walkthrough for audit preparation.

• Requires Associates Degree in Biology, Mechanics, Engineering or related field.
• 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 .

• Medical, Dental & Vision Benefits
• 401K Retirement Saving Plan
• Life & Disability Insurance
• Direct Deposit & weekly ePayroll
• Employee Discount Programs
• Referral Bonus Programs