KBI: US - Materials Coordinator

KBI Biopharma•Durham, NC

About The Position

The Manufacturing Material Coordinator checks the completeness of materials for Process Orders in a warehouse staging location and transfers those materials to designated manufacturing locations within the CMF GMP facility. Transfers are performed physically and systematically to support continuous manufacturing operations, traceability, and compliance with KBI procedures. The role also performs cycle counts, handles material requests, and restocks Kan-Ban locations. It may involve assisting Manufacturing with obtaining additional processing materials and moving staged materials from CNC locations to airlocks in processing suites. The position documents and records activities in electronic and paper systems and follows regulatory requirements, cGMPs, policy documents, and SOPs. Training must be maintained at 95% or greater. The coordinator wears required PPE, follows site safety guidelines, performs assigned support tasks such as staging and moving materials and other cleanroom work, and works shifts in a gowned cleanroom environment. The role requires handling materials including gaylords and totes, using cleaning agents and a powered air-purifying respirator (PAPR) or other respirator when transferring materials through airlocks. It includes inventory checks and restocking of Kan-Ban locations, communication with warehouse personnel about missing items, and computer-based material movement and training-related tasks. The position is considered essential personnel and requires seven-day-a-week work coverage, including when the company is closed, such as during inclement weather.

Requirements

Material Coordinator I: High school diploma or Associate degree and 0 or more years of experience.
Material Coordinator II: High school diploma or Associate degree and at least 18 months of experience.
Ability to read and interpret English documents, including safety rules, SOPs, and procedure manuals.
Ability to write routine reports and correspondence and communicate with coworkers and a supervisor.
Ability to follow written, oral, or diagrammed instructions and address problems involving several concrete variables in standardized situations.
Ability to perform basic arithmetic using whole numbers, common fractions, and decimals.
Ability to stand, walk, and wear steel-toe shoes; push, pull, squat, lift, reach, and carry materials and roll containers as needed, within the job's essential physical-function limits.
Ability to stand for long periods and bend, lift, push, carry, pull, and kneel.
Ability to work shifts, gown for a cleanroom environment, wear required PPE, and maintain a respirator seal; facial hair must be short enough to ensure a proper seal.
Ability to work seven-day-a-week coverage as essential personnel, including when the company is closed.
Computer skills with Word, Excel, email, and SAP.

Nice To Haves

Bio Works Certificate preferred.

Responsibilities

Check Process Order materials for completeness before manufacturing use.
Transfer materials from warehouse staging areas to manufacturing staging areas and designated manufacturing locations, physically and systematically.
Move gaylords and totes, including transferring materials through material airlocks using cleaning agents and a PAPR or other required respirator.
Perform cycle counts and inventory checks of Kan-Ban locations, and restock materials when minimum levels are reached.
Handle material requests and assist Manufacturing in obtaining additional materials as needed for processing.
Move staged materials from CNC locations to designated airlocks in processing suites as needed.
Communicate with warehouse personnel about missing items and ensure materials are accounted for.
Document and record activities in electronic and paper systems, including material movement and training-related functions.
Maintain required training at 95% or greater and comply with regulatory requirements, cGMPs, policy documents, and SOPs.
Wear proper PPE and follow safety guidelines and site policies.
Perform assigned general support tasks, including material staging, material movement, and cleanroom tasks.
Perform other tasks as assigned by the Supervisor or Manager.