Quality Representative 1st shift

Langham Logistics•Plainfield, IN

About The Position

The Quality Representative works in a cold storage facility with varying temperatures, including regular and sustained work in temperature-controlled cold-chain environments maintained between 2°C and 8°C (35.6°F and 46.4°F). The position is scheduled for the first shift, 7:00 a.m. to 3:30 p.m. The role performs quality inspections, sampling, and testing of incoming raw materials and components in accordance with GMP requirements to minimize cross-contamination. It also involves working in GMP clean rooms while following trafficking and gowning procedures, and performing associated cleaning and environmental monitoring. The representative supports accurate shipping, receiving, and inventory management by conducting quality checks on incoming and outgoing materials, identifying shipment discrepancies, documenting and segregating deviating materials, and collaborating with internal and external stakeholders. The position also supports client communication concerning quality issues and assists the Quality Manager with projects. Candidates must be able to perform the duties throughout their shift in refrigerated environments while wearing appropriate protective or cold-weather gear.

Requirements

High school diploma or GED.
1–2 years of experience in Quality Control or a related field within a GMP facility.
Ability to communicate effectively, verbally and in writing, with internal and external teams.
Analytical ability to assess information and data and make decisions regarding potential product-quality risks.
Ability to establish professional relationships and rapport with internal and external peers and management.
Ability to anticipate potential product and operational problems and risks and investigate solutions.
Organization skills to manage quality records with varying due dates, complete them on time, and maintain them in a readily retrievable format.
High attention to detail and accuracy.
Ability to bend, stoop, and lift up to 50 pounds as part of the daily work routine.
Ability to tolerate extended periods of work in refrigerated environments between 2°C and 8°C (35.6°F and 46.4°F), and safely perform essential duties throughout the shift while wearing required protective or cold-weather gear.

Nice To Haves

Clean room experience.
Forklift experience.

Responsibilities

Perform inspections, sampling, and testing on incoming raw materials and components in accordance with GMP requirements to minimize cross-contamination.
Work in GMP clean rooms, following trafficking and gowning procedures and performing associated cleaning and environmental monitoring.
Perform QC checks on incoming and outgoing materials to support accurate shipping and receiving.
Gather applicable information to determine whether a shipment has a discrepancy.
Ensure materials are accurately entered into deviation for inventory management.
Collaborate across departments on discrepancies or questions concerning deviating material.
Assist the Quality Manager with projects.
Communicate with clients about quality issues according to SOPs and/or the Client Quality Agreement.
Perform inventory counts, identify and track errors, and communicate with internal and external 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 and regulatory standards and client requirements.
Physically check incoming and outgoing materials for damage and other discrepancies.
Identify and report discrepancies between paperwork or orders and the physical product delivered.
Initiate and oversee quality records in QT9.
Collaborate with cross-functional teams to ensure products are accurately segregated and marked in the deviation area.
Ensure proper documentation of client communications concerning discrepancies and damages.
Provide courteous, professional service to internal and external stakeholders and present a positive image of Langham Logistics.