Quality Associate Level 2- Second Shift

Quality Associate II (Cleanroom & GMP Environment)

Overview

Our client is seeking a Quality Associate II to support quality assurance activities within a GMP-regulated warehouse and cleanroom environment. This role is responsible for material inspection, sampling, quality documentation, and compliance activities while ensuring adherence to GMP standards and client requirements.

Responsibilities

• Perform material inspections, sampling, and quality assessments for incoming and outgoing products.
• Review inventory, shipping, and receiving documentation for accuracy and compliance.
• Document deviations, discrepancies, investigations, and quality events within quality systems.
• Support GMP cleanroom operations, including adherence to gowning and contamination control procedures.
• Collaborate with Operations, Inventory, and Quality teams to resolve quality issues and manage non-conforming materials.
• Participate in continuous improvement and compliance initiatives.
  
  

Qualifications

• High School Diploma or GED required.
• 2 years of Quality Assurance, Quality Control, or Quality experience in a GMP-regulated environment.
• Required experience working in a cleanroom environment.
• Required experience performing material sampling activities.
• Experience within pharmaceutical, biotech, medical device, or other highly regulated industries preferred.
• Familiarity with quality management systems, deviation investigations, and GMP documentation.
• Strong attention to detail, organization, and communication skills.
  
  

Key Skills

Quality Assurance

• Quality Control
• GMP Compliance
• Cleanroom Operations
• Material Sampling
• Material Inspection
• Documentation Review
• Deviation Management
• Inventory Control
• Warehouse Quality
• Regulatory Compliance
  
  

Must-Have Requirements

• GMP-regulated industry experience
• Cleanroom experience (clearly demonstrated on resume)
• Material sampling experience (clearly demonstrated on resume)
• Quality Assurance or Quality Control background
• Strong documentation and investigation skills
• Experience working in a warehouse, manufacturing, pharmaceutical, biotech, or medical device environment