Quality Control Associate II - Raw Material Inspection (2nd Shift)
$30 - $32 per hourSiegfried Ltd
- # Quality Control Associate II – Raw Material Inspection (2nd Shift)Applylocations: Irvine, CAtime type: Full timeposted on: Posted Yesterdayjob requisition id: R26\_441"Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold the highest standards in safety, quality and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here, you'll find a workplace that values both collective success and your individual contributions—offering long-term opportunities to grow and make an impact.**Your Role:**QC Associate II, Raw Materials - 2nd Shift (2:00 PM - 10:30 PM) 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.**Your Profile:****Key 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.**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.**Preferred Qualifications*** Experience performing raw material inspection in a GMP-regulated pharmaceutical or biotechnology 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.Target Pay Range: $30-32/hour + 10% Shift Differential working on 2nd Shift*Individual compensation packages are based on various factors unique to each candidate, including skill set, experience, qualifications and other job-related reasons.***Your Benefits:*** Medical, Dental, Vision, Life* Voluntary Accident, Hospital, Pet* 401K* Generous Time Off StructureFounded in 1873 in Zofingen, Switzerland, Siegfried has grown into a global network of 13 sites across three continents. With a team of more than 3,800 highly skilled professionals, we take the innovations of our pharmaceutical customers to industrial scale and manufacture safe drugs for patients worldwide. As a fully integrated CDMO, Siegfried is one of the few organizations today that can carry out the development and manufacturing of APIs and finished dosage forms under one roof. This unique combination of know-how and experience makes us the most trusted partner in the pharmaceutical industry.
- J-18808-Ljbffr Siegfried Ltd
Vacancy posted 3 days ago
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