Materials Control Associate II
7555 Harmans Road Harmans, MD 21077 US
Shift: 7PM - 7AM - 2-2-3 ROTATION SCHEDULE
The Materials Control Associate II 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.
- 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 company 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 company 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 company 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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