Quality Control Analyst

Overview The QC Analyst will support late-stage clinical and commercial programs by performing and reviewing analytical testing in a cGMP-regulated environment. This position requires strong technical expertise in protein chemistry and proficiency with a range of analytical methods to ensure product quality and regulatory compliance. Responsibilities Conduct analytical testing for in-process, raw materials, release, and stability programs in accordance with established SOPs and regulatory requirements. Ensure full compliance with cGMP, ICH guidelines, and internal Quality Systems. Participate in and support investigations related to Out-of-Specification (OOS) results, deviations, and development of CAPA plans. Collaborate cross-functionally to support project execution, equipment qualification, and documentation of analytical data and reports. Assist in regulatory inspections and internal audits by providing data, documentation, and subject matter expertise. Maintain a high level of data integrity and ensure timely, accurate completion of laboratory documentation. Carry out additional responsibilities as needed, in alignment with company policies and procedures. Experience Minimum of 3 years of hands-on experience in a GMP-compliant QC laboratory environment. Proficient in key analytical techniques including: HPLC SDS-PAGE ELISA Capillary Electrophoresis Education Bachelor’s degree in Biotechnology, Biochemistry, Chemistry, or a closely related field. Additional information Seniority level: Associate Employment type: Full-time Job function: Science Industries: Pharmaceutical Manufacturing #J-18808-Ljbffr