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

Siegfried•Irvine, CA

2d•$30 - $32•Onsite

About The Position

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.

Requirements

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.
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.

Nice To Haves

Experience performing raw material inspection in a GMP-regulated pharmaceutical or biotechnology environment.

Responsibilities

Independently execute QC inspection and physical testing activities to support routine manufacturing and development programs.
Perform sampling of raw materials for chemistry and microbiology testing in cleanroom classified areas using appropriate aseptic techniques to minimize contamination risk.
Support development and improvement of raw material specifications in Labware LIMS 8 in collaboration with cross-functional teams.
Perform inspection activities in compliance with applicable GMP and GDP requirements and relevant regulatory standards.
Support and participate in internal and external audits, including direct interaction with auditors as needed.
Collaborate with Purchasing, QA, and suppliers to resolve issues related to nonconforming raw material lots.
Attend production and project meetings to provide updates on raw material testing and release status.
Maintain laboratory and sampling areas in a clean and organized state and support quality oversight of warehouse operations.
Perform other duties as assigned.