QC Chemist III

Siegfried•Irvine, CA

2d•$40 - $48

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: The Chemist III acts as a senior member of the QC Analytical team supporting raw material and finished product release, stability studies and method qualifications. The Chemist III provides advanced technical expertise in chromatographic analyses (HPLC/GC) and serves as chromatography subject matter expert within the laboratory. As a senior member of the team, this position assists with technical writing (Quality Investigations, Methods, Reports), instrument troubleshooting and laboratory improvement initiatives.

Requirements

Knowledge of quality systems, FDA, ICH and compendial requirements.
Demonstrated excellence in LC/GC analyses.
Experience executing method qualifications in a GMP environment.
Strong troubleshooting and root cause investigation skills.
Excellent written/oral communication skills.
Competency with routine software programs (MS Word, MS Excel).Proficient in Microsoft Excel and Word, Empower, Chromeleon, TrackWise, CDS systems and LabWare 8 for data analysis, chromatographic processing, quality management, and laboratory information management.
Aptitude to utilize advanced laboratory systems (Labware 8 LIMS, CDS systems).
Capable of using good reason and judgment to make and defend recommendations.
Positive team player in a fast-paced regulatory environment.
B.S / M.S Chemistry 8+ years of experience in a Chemistry Laboratory 5+ years of Experience in a GMP QC Laboratory

Nice To Haves

Experience in sterile drug product testing (Preferred)
2+ years leadership or mentoring experience (Preferred)
Experience in Customer-focused Laboratory Environment (Preferred)

Responsibilities

Independently execute complex QC chemistry testing to support routine manufacturing activities and stability programs.
Provide advanced technical expertise in HPLC and GC methods including assay, impurities, cleaning validation and stability-indicating methods.
Troubleshoot chromatographic methods and diagnose instrument performance issues. Coordinate minor repairs and vendor service as needed.
Participate in protocol design and execution for method transfers, verificationsverifications, and validations.
Assist in the performance of internal and external audits.
Assume role of SME and trainer for chromatography techniques and instrumentation.
Author or review laboratory investigations (OOS, OOT, Deviations) and technical reports.
Maintain laboratory working areas in a clean and organized state.
Utilize Labware 8 LIMS and chromatography data systems for review and approval activities.
Provide technical support to other departments within the organization.
Any and all other duties assigned by immediate supervisor.