QC Analyst II - Stability

Key Responsibilities

• Perform analytical testing of stability samples using HPLC, UPLC, GC, dissolution, UV-Vis, FTIR, and other compendial methods.
• Execute stability studies in accordance with approved protocols, product commitments, and internal procedures.
• Prepare samples, standards, diluents, mobile phases, and reagents required for stability testing.
• Operate, calibrate, troubleshoot, and perform routine maintenance on analytical instrumentation.
• Process, integrate, review, and interpret analytical data using Empower or equivalent chromatography software.
• Review chromatograms for peak integrity, retention time consistency, system suitability, and compliance with specifications.
• Support stability sample inventory management, pull schedules, storage conditions, and testing timelines.
• Trend and evaluate stability data to identify potential quality concerns, OOT results, and product performance trends.
• Document all analytical activities in laboratory notebooks, LIMS, and controlled records in accordance with GDP requirements.
• Participate in laboratory investigations related to OOS, OOT, atypical results, and stability-related deviations.
• Support method transfers, method verifications, and method validation activities as required.
• Assist with preparation and review of stability protocols, reports, and supporting documentation.
• Support regulatory inspections, customer audits, and internal audits related to stability activities.
• Maintain laboratory readiness through proper documentation, instrument logbooks, reagent control, and compliance with safety requirements.
• Collaborate with QA, Manufacturing, Regulatory Affairs, Stability Program Management, and other departments to support business priorities.

Education/Experience

• Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, Microbiology, or related scientific discipline.
• Minimum 2-4 years of pharmaceutical Quality Control laboratory experience in a cGMP-regulated environment.
• Experience performing analytical testing using HPLC, UPLC, and/or GC instrumentation.
• Experience supporting stability studies and stability testing preferred.
• Experience with dissolution, FTIR, Karl Fischer Moisture, UV-Vis, pH, conductivity, and wet chemistry testing preferred.
• Experience using laboratory systems such as Empower, LIMS, or equivalent data management systems preferred.

Job Competencies

• Working knowledge of pharmaceutical stability programs and ICH stability guidelines.
• Strong understanding of cGMP requirements, Good Documentation Practices (GDP), and Data Integrity principles.
• Knowledge of USP, EP, and compendial testing requirements.
• Proficiency with HPLC, UPLC, GC, dissolution, UV-Vis, FTIR, Karl Fischer, and associated laboratory techniques.
• Ability to review, interpret, and trend analytical and stability data.
• Experience investigating OOS, OOT, and atypical laboratory results.
• Strong organizational skills with the ability to manage multiple studies and testing timelines simultaneously.
• Ability to work independently with minimal supervision while maintaining a high degree of accuracy.
• Strong written and verbal communication skills.
• Proficiency with Microsoft Office applications including Excel, Word, and PowerPoint.