Quality Representative Level 2 - Life Science Div 2nd Shift

Langham Logistics, Inc•Easton, PA

3d•Onsite

About The Position

The Quality Associate contributes to meeting Langham Logistics goals of exceptional Client service, quality, process improvement, and profitability. This role involves performing inspections, sampling, and testing on incoming raw materials and components following GMP to minimize cross-contamination. The associate will operate in GMP cleanrooms, adhering to trafficking & gowning procedures, and ensuring associated cleaning and environmental monitoring are completed before performing GMP activities. Collaboration among departments is key for handling discrepancies or questions regarding deviating material or processes. Ensuring proper client communication regarding Quality issues, in accordance with SOPs and/or the Client Quality Agreement, is also a critical function. The role includes 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.
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.

Nice To Haves

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 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.
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.