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.
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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
