Senior Quality Control (QC) Analyst

Job Description

Job Description

Description:

• Perform in-process, release, and stability testing of GMP samples using HPLC/UPLC platforms, residual ELISAs, and other qualified analytical assays.
• Execute analytical testing strictly per validated/qualified methods and SOPs.
• Independently perform complex analytical assays and support laboratory investigations with minimal supervision
• Lead and support analytical development activities and nonclinical sample testing for IND-enabling and CMC/BLA programs.
• Author, revise, qualify, and validate analytical test methods in alignment with ICH guidelines and internal quality standards.
• Document deviations, support root-cause investigation, and contribute to CAPA implementation.
• Maintain laboratory operations by managing inventory, preparing reagents and reference standards, and ensuring safe and compliant workflows.
• Ensure equipment readiness by performing routine maintenance, monitoring calibration, and coordinating service as needed.
• Provide peer review of GMP data packages and validation documentation.
• Train, mentor, and provide technical guidance to junior QC Analysts.
• Maintain complete and contemporaneous GMP documentation to support data integrity.
• Support regulatory inspections, audits, and client interactions.
• Participate in continuous improvement initiatives to enhance QC efficiency, compliance, and technical robustness.

• Minimum 3-5 years of hands-on QC Chemistry laboratory experience in a GMP-regulated environment
• Strong working knowledge of cGMP regulations, data integrity, and applicable ICH/USP analytical guidelines.
• Demonstrated experience with method development, validation, qualification, and transfer.
• Proven ability to independently troubleshoot complex analytical assays and resolve instrumentation or method-related issues.
• Strong attention to detail and a high level of accuracy in data generation, documentation, and review under GMP guidelines.
• Excellent oral and written communication skills.
• Strong problem-solving aptitude with the ability to identify root causes and support effective corrective actions.
• Demonstrated ability to work both independently and collaboratively within a small, high-performing QC team.
• High motivation to meet the operational and compliance demands of the QC department and cross-functional partners.
• Experience supporting regulatory audits, QA inspections, or client audits is desirable.
• Bachelor’s degree in a scientific discipline with 3–5 years of experience in a GMP/QC environment, or Master’s degree in a scientific discipline with 1–3 years of experience in a GMP/QC environment.