Quality Associate - Life Science 2Nd Shift

This is a 2d shift 4pm-12:30am position

Summary

• 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.

Key Responsibilities

• 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.

Qualifications & Requirements

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

Physical movements including bending, stooping, and lifting up to 50 pounds as part of daily work routine.  This role requires regular and sustained work within temperature-controlled cold-chain environments maintained between 2°C and 8°C (35.6°F to 46.4°F). The individual must be able to perform job duties for the duration of their shift within these temperature ranges while wearing appropriate protective or cold-weather gear as required.

Candidates must acknowledge and demonstrate the physical ability to tolerate extended periods of work in refrigerated environments and to safely perform all essential job functions under these conditions.

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