Position Title: Sr. Materials Handler
Work Location: Newark, California
Assignment Duration: 2 months
Work Arrangement: Onsite

Position Summary: The incumbent will be a part of the Supply Chain organization -Materials Management and provide technical support in the areas of inventory management, logistics management, process improvements and 3PL relationships. GMP warehouse activities, revising SOP’s / Forms, supports with initiating and processing Deviations, NCRM’s and Change Controls.

Background & Context: The successful candidate will be responsible for the coordination and management of GMP documentation activities supporting our organization’s Materials Management department. This position requires close collaboration with QA, QC and Document Control to ensure that all documentation activities are completed and filed within the required timelines. A successful applicant in this position should have flexibility, excellent organization, excellent time and project management skills, attention to detail, good interpersonal skills and work with minimal supervision. Experience with Clinical material, Production and Manufacturing processes is required.

Key Responsibilities:

• Support for the physical and administrative tasks involved in storing and organizing materials, parts, supplies and equipment
• Count products for specific Part Numbers
• Lifts heavy items and may operate a pallet jack
• Examines, stocks and moves materials to inventory and manufacturing lines
• Follow policies, procedures and material control systems
• Ensures non-GXP materials are ordered and in stock to meet company requirements, while maintaining acceptable inventory levels
• Understanding of 5’s and Lean concepts
• Provide reporting to manager on Inventory
• Supports with keeping the inventory tracker up to date and escalate if there is any deference
• Identify materials approaching expiration
• Work with Manufacturing and procurement on GMP raw materials
• Support with writing or reviewing SOP’s and Forms related to Materials management
• Support with Deviations and CAPA’s
• Supports with maintaining KPI’s

Qualification & Experience:

• 3-5 years of controlled warehouse experience or equivalent training background in materials handling
• Experience in cGMPs and FDA regulated environments preferred
• 3-5 years Inventory control experience
• 3-5 Shipping and Receiving experience
• 3-5 Years’ experience with ERP system
• Write and review SOP’s, Forms, NCRM’s and support with deviations and CAPA’s
• DOT and IATA Experience
• Able to lift up to 50 lbs.
• Working knowledge of cGMPs for biopharmaceuticals, excellent writing and organizational skills, excellent communication skills, an ability to work effectively with others in a dynamic environment
• Experience working with CRO/CMO partners, QA/QC and other outside regulatory agencies
• Experience using warehousing ERP systems (SAP, Oracle, MS D365) for the process and tracking of raw materials and finished goods
• Proficiency in MS Office (Word, Excel) software, QUMAS (or other document control system)
• Oracle, SAP, Microsoft Dynamics or other ERP systems experience
• Ability to make decisions and recommendations based on sound rational and proper cGMP/GLP practices.

Working Conditions & Physical Demands (If Applicable): Able to lift up to 50 lbs. Lifts heavy items and may operate a pallet jack.

Additional Information (If Applicable): Education Minimum Required: Some college/BA/BS Degree with 3+ years of related experience in a cGMP environment or equivalent cGMP warehouse experience. Minimum high school diploma.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position's pay range is $31.89/hr - $33.23/hr.