Quality Control Analyst III

3 weeks ago

Ventura CA, United States Astrix Full time

Our client, a global CDMO, offering products and services across the drug development spectrum is looking for a skilled QC Analyst III to join their team in Ventura County, CA Job Title: QC Analyst III Location: Ventura County, CA Job type: 6 month contract - hire Pay rate: $37 - $39/ hr. Job Summary: We are seeking a highly skilled and detail-oriented Senior QC Analyst to perform complex analytical testing in support of pharmaceutical product development and manufacturing. The ideal candidate will have advanced experience in chromatography techniques (e.g., HPLC, UPLC, GC), method validation, data analysis, and regulatory compliance. This position plays a critical role in ensuring product quality, supporting investigations, and driving continuous improvement across the QC function. Key Responsibilities: Perform complex analytical testing including Liquid Chromatography (HPLC/UPLC), Gas Chromatography (GC), and other instrumental and wet chemistry techniques. Troubleshoot analytical instruments and resolve method or equipment-related issues. Participate in and assist with test method validations, verifications, and transfers. Evaluate and analyze test data to identify trends, outliers, or potential issues. Support OOS (Out of Specification) and OOT (Out of Trend) investigations, including CAPA (Corrective and Preventive Action) documentation. Coordinate testing activities with external laboratories, including raw material and specialized testing. Execute, author, and review SOPs, test methods, protocols, reports, investigations, change controls, and data summaries. Utilize risk assessment and root cause analysis tools (e.g., 5 Whys, Fishbone) to support investigations and process improvements. Manage aspects of the stability program, including scheduling, testing, and reporting, and investigate aberrant stability results. Qualifications: Bachelor's or Master's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific field. 3–6+ years of relevant experience in a regulated laboratory environment (pharmaceutical, biotech, or similar). Strong technical expertise in HPLC, UPLC, GC, and other analytical techniques. Working knowledge of cGMP regulations, ICH guidelines, and regulatory expectations. Experience with method validation and stability programs preferred. Ability to manage multiple tasks and work independently in a fast-paced environment. Experience with electronic data systems (e.g., Empower, LIMS, TrackWise, MasterControl). Note: This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you

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