Job Description
Title: Materials Control Associate
Location: Severn, MD
Duration: 6 Months
The Materials Control Associate III is accountable for GMP (Good Manufacturing Practices) materials control/warehousing operations for a Phase II/III GMP biopharma manufacturing facility. The position requires practical experience and knowledge of a variety of activities such as materials receiving/processing, logistical support in a manufacturing facility, electronic inventory control and distribution/shipping of products. Be able to train peers in functional execution.
KEY RESPONSIBILITIES
• Will distribute materials for GMP operations following approved procedures. This includes assisting in the reconciliation of all GMP materials after client campaigns. (primary duties)
• Proper labeling accountability assessing and adherence. (primary duties)
• Reconciling inventory discrepancies, cycle counts, investigate and troubleshoot root cause inventory deficiencies. (primary duties)
• Attention to detail. (primary duties)
• Reviews of GMP documentation associated with material control (material specifications, inbound material inspection forms, SOPs, inventory records, item request forms etc.)
• Will take part in the receipt of all GMP materials - rectify discrepancies, matching vendors documentation against Catalent requirements (GMP and accounting).
• Ensure alignment with applicable procedures relating to shipment of CRT, Ambient, Cold-Chain shipments.
• Works closely with QA (Quality Assurance) to quarantine and release all GMP materials on time
• Participation in the organization and cleanliness of the warehouse will be critical
• Aids in the training of junior personnel
• Will work closely with various departments at Catalent and aid as needed. This may include support for pre-clinical projects
• Assessing the Materials Control operation on a continuing basis and supplying recommendations for improvement is encouraged.
• Compile and maintain inventory records
• Deviation, CAPA (Corrective Action Preventive Action) and Change Control knowledge.
• Understanding of process quality controls that support raw material integrity.
• Takes receipt and inventory control of Catalent generated material (cell banks, bulk protein, etc.)
• Aids with performing internal audits
• Works under general supervision to meet project goals.
• All other duties as assigned.
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