About this position
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.
Salary Information
$80000.00 - $100000.00
Annual Salary