Quality Control Associate II – Raw Material Inspection (2nd Shift)

Your Role

The Quality Control Associate II (Raw Material Inspection), 2nd Shift is an individual contributor within the QC Raw Materials team responsible for supporting raw material receipt, inspection, sampling, physical testing, and release of materials used in the manufacture of sterile drug products. The role supports development, revision, and maintenance of raw material specifications within Labware LIMS 8, ensuring alignment with compendial and regulatory requirements. The position also supports quality investigations such as deviations, OOS, and vendor corrective actions. This role includes hands-on sampling of bulk materials in classified cleanroom environments, physical testing using laboratory instrumentation, and dimensional inspection of components. The associate collaborates cross-functionally with Chemistry, Microbiology, Engineering, Purchasing, Warehouse, and Quality Assurance to ensure materials meet specifications and are released in a timely manner.

Required Qualifications

• Bachelor’s degree in Chemistry, Biology, or other pharmaceutical-relevant scientific discipline.
• Minimum of 3 years of experience in QC or QA within an FDA-regulated industry.

Required Skills and Competencies

• Working knowledge of quality systems and regulatory expectations including FDA and compendial requirements.
• Familiarity with ANSI/ASQ sampling plans.
• Ability to perform aseptic sampling, use precision measurement tools, and learn new laboratory instrumentation.
• Strong written and verbal communication skills with effective documentation practices in a GMP environment.
• Strong analytical thinking and judgment with the ability to make and defend recommendations.
• Ability to work effectively in a fast-paced, cross-functional team environment.

Work Environment

This role requires hands-on laboratory and cleanroom work, including sampling of raw materials in classified environments and use of appropriate personal protective equipment.