Quality Representative 1st shift

Langham Logistics, Inc•Plainfield, IN

14h•Onsite

About The Position

This position is in a cold storage facility with varying temperatures. The role involves performing inspection, sampling, and testing on incoming raw materials and components following GMP to minimize cross-contamination. The Quality Representative will operate in GMP clean rooms, adhering to trafficking and gowning procedures, and performing associated cleaning and environmental monitoring. Key responsibilities include ensuring accurate shipping and receiving by performing QC checks on all incoming and outgoing materials, gathering information to determine shipment discrepancies, and ensuring accurate inventory management by properly documenting materials in deviation. The position requires collaboration among departments on discrepancies or questions for deviating material, assisting the Quality Manager with projects, and ensuring proper client communication regarding quality issues according to SOPs and Client Quality Agreements. Additionally, the role involves performing accurate inventory counts, identifying and tracking errors, and communicating with external and internal stakeholders to support case management.

Requirements

High school diploma or GED required
1-2 years’ experience in Quality Control or related field within a GMP facility
Ability to effectively communicate to internal and external teams both verbally and written in an appropriate manner
Ability to thoughtfully analyze a wide variety of information and data to make key decisions regarding potential risks associated with product quality
Ability to establish professional relationships and rapport with internal and external peers and management
Ability to anticipate potential problems and risks related to product, operations, and investigate solutions
Ability to manage multiple quality records with various due dates to ensure timely completion and maintain records in a readily retrievable format
High detail orientation and accuracy

Nice To Haves

Clean room experience preferred
Forklift experience a PLUS

Responsibilities

Perform inspection, sampling, and testing on incoming raw materials and components following GMP to minimize cross-contamination
Operate in GMP clean rooms following trafficking & gowning procedures and performing associated cleaning and environmental monitoring
Ensuring accurate shipping and receiving by performing QC checks on all incoming and outgoing materials
Gathering all applicable information to determine if a shipment has a discrepancy
Ensuring accurate inventory management by ensuring materials are dropped into deviation accurately
Collaborate among departments on discrepancies or questions for deviating material
Assisting the Quality Manager with projects
Ensuring proper Client communication as it relates to Quality issues according to the SOPs and/or the Client Quality Agreement
Performing accurate inventory counts, identifying and tracking errors, and communicating with external and internal stakeholders to support case management
Work according to Langham Logistics company values, policies and procedures
Meet established quality and productivity metrics
Keep work areas neat and clean
Accept or reject material based on quality/regulatory standards and Client requirements
Physically check all incoming and outgoing materials for damage and other discrepancies
Identify and report discrepancies between paperwork/orders and physical product delivered
Initiate and oversee quality records in QT9
Collaborate with cross-functional teams to ensure product accurately segregated and marked in deviation area
Ensuring proper documentation for client communication as it relates to discrepancies and damages
Provide courteous, professional service to both internal and external stakeholders
Present a positive image of Langham Logistics