Quality Control Raw Materials Associate II (2nd Shift)

Siegfried•Irvine, CA

5d•$27 - $30•Onsite

About The Position

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 - 2nd Shift Position (2 PM - 10:30 PM) The Quality Control Associate II (Raw Material Inspection) will act as an individual contributor in the QC Raw Materials team supporting raw material receipt, inspection, testing (physical methods), and release. The QCRM associate will support the development, revision, and rationalization of raw material specifications using the LIMS system (Labware 8), including application of compendial and regulatory requirements, and will execute associated quality investigations (OOS, Deviations, Vendor Corrective Actions, etc.). A portion of the workload involves physical testing using instrumentation, sampling of bulk materials in clean room environments, and dimensional analysis of components used in the manufacture of sterile drug products. The QCRM associate will frequently collaborate with colleagues from the Chemistry, Microbiology, Engineering, and QA departments to ensure that raw materials used in drug products meet internal specifications and are released in a timely manner.

Requirements

Knowledge of quality systems, FDA and compendium requirements.
Familiarity with ANSI/ASQ sampling plans.
Ability to sample aseptically, perform fine measurements using tools and learn new instrumentation.
Advanced written/oral communication skills and advanced computer skills.
Capable of using good reason and judgment to make and defend recommendations.
Positive team player in a fast-paced environment.
B.S. in Chemistry, Biology or other Pharmaceutical-relevant degree
3+ years of Experience in QC or QA
3+ years of Experience in FDA Regulated industry

Nice To Haves

Experience performing Raw Material Inspection (Preferred)

Responsibilities

Independently execute QC inspection and testing to support routine manufacturing activities and new clinical/development products.
Perform sampling of raw materials for chemistry and microbiology testing in clean room classified areas, minimizing contamination using aseptic technique.
Collaborate with tech transfer teams to design raw material specifications for new materials and improve specifications for existing materials.
Become proficient in use of Labware LIMS 8.
Perform inspection in compliance with relevant regulations. All activities are performed in GMP/GDP environment.
Support and participate in internal and external audits, including direct interaction with auditors when discussing raw material inspection processes and records
Collaborate with purchasing, QA and the supplier to resolve issues with nonconforming batches of raw materials.
Attend production and project meetings as representative of QCRM group to communicate status updates on pending raw material release.
Maintain the working areas in a clean and organized state.
Assist in Quality oversight of warehouse operations.
Any and all other duties assigned by immediate supervisor.