Senior Quality Compliance Specialist - Thousand Oaks, CA

Title: Quality Control Validation Scientist (AQC/QCM)Location: Thousand Oaks, CADuration: 12+ Months (Possible extension)Summary:The Quality Control Validation Scientist will support Quality Control (QC) activities within the Analytical Quality Control (AQC) and Quality Control Microbiology (QCM) departments in a cGMP-regulated environment. The role focuses on analytical method transfer, validation, execution, and continuous support of laboratory testing activities, including raw material analysis and microbiological methods.Key Responsibilities:Lead and support analytical method validation and method transfer activities for laboratory procedures.Execute test plans and protocols, and support resolution of deviations, discrepancies, and technical issues.Troubleshoot analytical and microbiological methods to ensure reliable and compliant outcomes.Ensure laboratory instruments and equipment remain in a validated state in accordance with regulatory and company standards.Prepare, review, and approve technical documents including validation protocols, reports, and lifecycle documentation.Support raw material qualification and testing for new product introductions.Apply scientific principles and statistical tools to analyze data, solve problems, and provide recommendations.Support qualification activities such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for equipment, facilities, and utilities.Assist with Computer System Validation (CSV) activities including SCADA, MES, and laboratory systems where applicable.Ensure project deliverables are completed within defined timelines and milestones.Maintain compliance with cGMP, USP, ICH, 21 CFR, and other applicable regulatory standards.Collaborate in a dynamic environment requiring multitasking, attention to detail, and strong time management.Qualifications:Bachelor's degree in Biotechnology, Microbiology, Pharmacy, Chemistry, or related field.Minimum 1+ year of experience in analytical development, validation, or QC in pharmaceutical/biopharmaceutical or regulated manufacturing environments (advanced degree acceptable in lieu of experience).Strong technical writing skills with experience preparing regulatory-compliant documents and reports.Solid understanding of analytical methods, method validation, and laboratory operations.Basic to intermediate knowledge of statistical data analysis and interpretation.Strong familiarity with cGMP, QSR, USP, 21 CFR, and ICH guidelines.Ability to work independently with minimal supervision and manage multiple priorities.Proficiency in Microsoft Office tools.Strong organizational skills, attention to detail, and problem-solving ability.Preferred (Nice to Have):Experience with KNEAT or other paperless validation systems.Exposure to lifecycle validation documentation and electronic validation platforms.Experience in commissioning and qualification (IQ/OQ/PQ) of equipment, facilities, and utilities.Knowledge of Computer System Validation (CSV) for systems such as SCADA and MES.Experience with QC/Micro laboratory instrument qualification and method validation.Work Environment:Work in laboratory and office settings, including controlled or cleanroom environments requiring gowning.May involve handling chemicals such as acids, alcohols, and buffers with appropriate safety measures.Ability to work extended hours as required (beyond standard 40-hour workweek).Regards,Abhishek KumarSenior RecruiterAbKumar@alphambe.com