Quality Associate Level 2 - Life Science Division

Job Description

Job Description

**This is a 2nd shift role ** 2pm-10pm

Summary 

The Quality Associate contributes to meeting Langham goals of exceptional Client service, quality, process improvement, and profitability by performing the following tasks: Ensuring accurate shipping and receiving by performing QC checks on all incoming and outgoing materials;

• Perform inspection, sampling, and testing on incoming raw materials and components following GMP to minimize cross-contamination
• Operate in GMP cleanrooms following trafficking & gowning procedures and ensuring associated cleaning and environmental monitoring completed prior to performing GMP activities.
• Collaborate among departments on discrepancies or questions for deviating material or processes
• Ensuring proper Client communication as it relates to Quality issues according to the SOPs and/or the Client Quality Agreement.
• Identifying and tracking errors, communicating with external and internal stakeholders to support case management.

Key Outcomes Expected 

The Quality Representative is expected to:

• 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.

Critical Skills, Knowledge and Behaviors 

• Communication – ability to effectively communicate to internal and external teams both verbally and written in an appropriate manner. 
• Analytical Skills – ability to thoughtfully analyze a wide variety of information and data to make key decisions regarding potential risks associated with product quality.
• Teamwork - ability to establish professional relationships and rapport with internal and external peers and management. 
• Proactiveness – ability to anticipate potential problems and risks related to product, operations, and investigate solutions.
• Organization – 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.

Education and Experience 

• High school diploma or GED required.
• 1-2 years’ experience in Quality Control or related field within a GMP facility 
• Forklift experience a PLUS 

Work Environment and Physical Demands

Work is performed in a warehouse/office/external environment with multiple zones of varying temperature: frozen, refrigerated, controlled room temperature, and environmental.  Physical movements including bending, stooping, and lifting up to 50 pounds as part of daily work routine.  Will be working on concrete in a warehouse environment (subject to heat and cold).