Qc Specialist Ii, Analytical Investigations

• Lead investigations into QC Analytical deviations, OOS/OOT/OOE results, and other quality issues
• Serve as a key point of contact during audits and inspections, ensuring timely and compliant responses
• Draft and revise change controls, technical reports, cGMP documents, and protocols
• Perform QC analytical testing, review data, and identify trends to proactively address risks
• Assist in managing analytical equipment to maintain compliance and efficiency
• Collaborate cross-functionally to close out quality events and audit findings on time
• Help shape and refine QC processes that support continuous improvement

• Bachelor’s degree in Analytical Chemistry, Chemistry, Pharmaceutical Sciences, or related field
• 2–5 years of QC Analytical Chemistry experience (pharma experience preferred)
• Hands-on experience with UPLC, HPLC, GC, FTIR, UV/VIS, Karl Fisher, Particle Size Analyzer, Densitometer, and Osmometer
• Solid understanding of cGMP, ICH, USP, and global compendia guidelines, especially in analytical method validation and stability studies
• Strong organizational and documentation skills, technical writing ability, and excellent communication skills (written and verbal)
• Ability to thrive in a fast-paced, dynamic environment, juggling multiple priorities while maintaining a sharp eye for detail
• Proficiency in MS Office
• experience with lab-based data management systems a plus

experience with lab-based data management systems a plus

• Be part of a collaborative team where your expertise directly impacts patient safety and product quality
• Gain exposure to diverse analytical techniques and regulatory processes
• Opportunity to work in a GMP environment supporting both clinical and commercial product lifecycles
• Professional growth through hands-on problem solving, cross-functional collaboration, and continuous learning