Admin, Quality Assurance

Ajinomoto Health & Nutrition North America, Inc.•Raleigh, NC

6d•$29 - $35•Onsite

About The Position

Responsible for Quality Assurance activities to include batch record issuance/review, production labels, release of product, generation of shipping orders and other associated activities for the routine operations at the North Carolina plant, in accordance with cGMP regulations.

Requirements

High school diploma or GED
3 to 4 years’ experience working in a regulated cGMP setting
An equivalent combination of education, experience and training may substitute
Knowledge of current Good Manufacturing Practices (cGMP) with special attention to good documentation practices and be detailed oriented
Ability to work independently with little to no direction and to take initiative within scope of work responsibilities
Ability to prioritize work, anticipate department needs, and plan accordingly for needs
Ability to multi-task and adapt to changing priorities
Ability to demonstrate effective written and oral communication and people skills
Ability to communicate across department lines
Desire to cross-train and support other core functions within the department
Ability to support transition from paper-based system to electronic-based systems
Demonstratable computer skills to include MS Word and Excel

Nice To Haves

Experience with LIMS, SAP and Bartender a plus

Responsibilities

Generate labels for finished goods as required to support production schedule
Maintain master label templates and record archives for the Purification and Mixing and Packaging production processes
Reconcile labels used by production and warehouse departments to ensure 100% accountability of labels produced
Monitor and maintain appropriate label stock and supplies
Verify each product selected for use in the Mixing and Packaging department is suitable for the intended use and/or the customer
Verify selected products have been released for use by production
Review and verify the disposition of DMR material to ensure it meets the quality requirements for its intended use
Generate the batch production records for production and warehouse processes as outlined in the document control procedures and cGMP requirements to support the production schedule
Accurately identify each production record with product name and lot number
Maintain the BPR and SOP files distributed to the Label Control area in accordance with document control procedures and cGMP requirements
Receive and review for accuracy process orders from Supply Chain for PB40 and PB30 product release
Review customer specifications and shipping requirements for accuracy
Obtain appropriate shipping documentation for process orders (COAs, using SAP, SharePoint, shared drives and internal customer support)
Quality release process orders and associated documentation (packing list, COA, specific customer documents) to Warehouse for shipment release
Review SAP for shipment status and forward customer documentation
Quality review data entered by Quality Control in LIMS for accuracy in comparison to Data Documentation Sheets for crude and raw material release
Perform Transfer Orders in SAP to move crude and raw material stock to unrestricted for production use
Review COAs received from Supply Chain for accuracy and manually enter batch data and product grade in SAP for distribution to customer for PB30 product release
Review Lot Mark Sheets and COAs from Supply Chain for accuracy and Quality approve for Label Control for J-Lot and V-Lot product release
Review and sign-off on Quality approval of completed BPRs from production and warehouse department (Mixes, Repacks, etc)
Other duties as assigned