QC Analytical Specialist
About The Position
The QC Analytical Specialist serves as the subject matter expert (SME) for UHPLC and other analytical techniques within the Quality Control laboratory. This role is responsible for performing, leading, and interpreting analytical testing to ensure the identity, potency, and quality of raw materials and excipient samples in compliance with cGMP, SOPs, and regulatory requirements. The specialist will troubleshoot laboratory testing and equipment issues related to UHPLC, provide technical guidance and training to QC Analysts, and lead method validation and verification activities. This position requires the ability to manage multiple projects, prioritize tasks effectively, and adapt to changing priorities to meet business objectives.
Requirements
- Bachelor of Science Degree
- Minimum of 5 years of experience in a GMP-regulated QC laboratory, with demonstrated expertise in HPLC/UHPLC testing.
- Strong knowledge of UHPLC analytical techniques, laboratory instrumentation, and cGMP compliance.
- Experience with laboratory investigations, deviations, OOS/OOT reporting, and corrective actions.
- Experience with Quality Management Software, preferably MasterControl.
- Knowledge of regulatory guidelines including FDA, ICH, USP, and EP.
- Proficiency with Microsoft Office (Word, Excel, Outlook, SharePoint) and ERP systems.
- Comprehensive knowledge of UHPLC method development, method transfer, and the preparation and execution of analytical protocols.
Responsibilities
- Analytical Testing & Method Expertise Develop, implement, and maintain UHPLC/HPLC methods and analytical protocols.
- Lead method verification, method transfer, and validation activities in accordance with USP and ICH guidelines.
- Review and interpret analytical data, ensuring accuracy, completeness, and compliance with cGMP, SOPs, and regulatory expectation
- Investigation & Troubleshooting Lead investigations of deviations, out-of-specification (OOS), or out-of-trend (OOT) results related to analytical testing.
- Troubleshoot laboratory equipment and method performance issues, related to UHPLC, to identify root causes and implement corrective actions.
- Support complaint investigations directed to Quality Control, providing technical assessment and corrective action.
- Documentation & Compliance Create, revise, and maintain SOPs, protocols, and other controlled documents.
- Ensure proper handling, storage, and documentation of laboratory reagents, standards, and samples.
- Maintain compliance with cGMP regulations, including adherence to data integrity principles.
- Equipment & Laboratory Management Maintain, calibrate, and troubleshoot laboratory instruments to ensure consistent, accurate, and reliable test results.
- Drive continuous improvement initiatives to enhance laboratory efficiency, reduce test variability, and strengthen product quality.
- Leadership & Training Serve as the SME for laboratory techniques, analytical methods, and GMP practices.
- Train and mentor QC Analysts on UHPLC and other analytical techniques.
- Lead special projects and support cross-functional initiatives as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
