Associate I, Materials Control Distribution
Job Description
The Materials Control Associate I 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, SOP’s, 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 the 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’s 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.
QUALIFICATIONS:
* Education: GED required.
* Experience: At least 6 months of general warehouse experience.