Quality Control Specialist

Responsibilities:

• Develop and maintain stability study plans, protocols, and reports in alignment with ICH guidelines; coordinate, review, trend, and summarize test data for raw materials (including cell banks and plasmids), drug substance, and finished product
• Manage daily stability operations including receipt and processing of samples, placement into storage chambers, sample pulls, aliquoting, and coordination of internal or external testing
• Oversee and track testing activities and data flow from both internal teams and contract laboratories
• Collaborate with Quality Assurance and other cross-functional groups to assist in investigations and documentation related to deviations, CAPAs, and OOS/OOT events
• Upload and manage stability data in electronic systems to support the generation of formal reports
• Apply statistical tools to analyze and trend stability data
• Ensure strict compliance with current Good Manufacturing Practices (cGMP) and internal procedures
• Adhere to safety regulations and maintain accurate, compliant documentation

Qualifications:

• Solid understanding of cGMP, ICH, FDA, and EU regulations related to stability
• Familiarity with aseptic processing principles and contamination control practices
• Excellent written and verbal communication skills, with the ability to collaborate effectively across teams
• Strong organizational skills and attention to detail in a dynamic, fast-paced environment
• Ability to work both independently and within a team structure