QC Specialist II/III - Chemistry

Role: Quality Control Specialist – Chemistry, providing technical expertise in analytical instrumentation within a QC laboratory. Main objectives include ensuring instrument performance, compliance with data integrity standards, and supporting regulatory requirements (FDA, ICH, JP). Responsibilities encompass overseeing instruments like HPLC, UPLC, GC, LC-MS, and others; authoring and maintaining technical documentation, risk assessments, and user specifications; developing training materials; troubleshooting instrument issues; and identifying process improvements. Requirements: Bachelor's or Master's degree in Chemistry with 1–4 years of lab experience, strong understanding of instrument operation, troubleshooting, and data integrity regulations. Preferred skills include experience with QC systems (Empower, LIMS, TrackWise), technical writing, and cross-functional communication. High-value specifics: focus on analytical instrumentation supporting biopharma QC, likely in pharmaceutical manufacturing or drug development contexts, emphasizing compliance, data accuracy, and lifecycle management of lab equipment. Collaboration involves working closely with analysts, quality assurance, and regulatory teams. Location and travel details are not specified, but the role typically involves laboratory-based, on-site work with an emphasis on regulatory compliance and technical excellence.