Role Summary
The purpose of the Material Handler 2 is to ensure raw materials are ready and available at the Novato site to support the Commercial and Clinical Manufacturing Facilities. The role may require off-hours support, including shift work, weekends, off hours and holidays.
Responsibilities
- Receives, verifies and coordinates raw material receipts and returns from warehouses to manufacturing facilities and vice versa.
- Contact for raw material issues and reconciliation.
- Coordinates and reconciles raw materials that are in quarantine.
- Performs audit of frequently used items to ensure inventory accuracy.
- Coordinates the removal of expired raw materials and expired in-process inventory.
- Maintains accurate inventory records for approved GMP raw materials, components and supplies.
- Performs cycle counts of approved GMP material inventory as assigned using ERP system.
- Complies with EHS&S safety guidelines, especially those directly related to the operation of warehousing equipment such as pallet jacks and forklifts.
- Performs pre-weigh for kitting of buffers, solutions, and media.
- Performs sampling of raw material chemicals.
- Maintains warehouses and sub-inventory areas in an audit-ready state.
- Complies with cGMP Documentation, Practices and Regulations.
- Transports and distributes approved GMP raw materials, components and supplies to the designated manufacturing facilities.
- Participates with SOP and Work Instruction updates as required.
- Provides suggestions for process improvements and participate in implementation.
- Manages Kanban system to support manufacturing operations.
- Required to work in a clean room environment.
- Demonstrates the concepts of the network neighborhood.
- Inputs data for trending defined metrics.
- Assists with performing training activities.
- Assists with action items assigned during deviation investigations, corrective/preventative actions (CAPAs), and change requests.
- Other duties as assigned.
Qualifications
- Required: Proficient in Microsoft Office applications.
- Required: Ability to follow Standard Operating Procedures (SOP).
- Required: Must possess a valid California driverβs license.
- Required: Effective written and verbal communication skills.
- Required: Detail oriented.
- Preferred: 1-2 years experience in a GMP warehousing environment.
- Preferred: Demonstrated leadership skills.
- Preferred: Knowledge in MES, SAP, Oracle EBS, CMMS, Veeva and LabWare LIMS systems or similar operating databases.
- Preferred: Experience in continuous improvements.
Education
- High School Diploma or equivalent required.
- AA/AS or BA/BS in Life Sciences or related discipline preferred.
Additional Requirements
- Consists of strenuous, repetitive work. The following list of physical movements may be used on a daily basis: pulling, pushing, bending, reaching, climbing stairs and ladders, and kneeling.
- Independently have the ability to regularly lift, dispense, push and/or pull items with an average weight of 30 pounds.
- May require work around loud equipment.
- The use of personal protective equipment will be required.
- Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.
- Required Work Hours: Sunday - Wednesday. 7am - 6pm PST.