• Ensure timely submissions of reports to Quality Assurance and Regulatory Affairs.
• Ensure the accurate execution of the stability program for all products; which includes ensuring that samples are pulled in a timely manner which resulted in roughly 2 million in revenue.
• Monitor stability storage conditions to ensure appropriate temperatures and humidity are maintained
• Author, prepare, and mange Stability Summary Reports.
• Author, prepare, and review Stability Protocols to be issued to Clients.
• Provide support and guidance in daily operations of sample management and testing.
• Work directly with customers to update and confirm schedules and deadlines.
• Develop project plans, develop and mange timelines, identify, and respond to critical barriers.
• Support Quality Control Managers to align in-process and outsource testing for client’s individual batches.
• Track company milestones for Stability department to improve overall rate and performance.
• Responsible for attending client meetings to follow up on any Quality Control questions or concerns or corrective actions that need to be made.
• Work closely and directly with Program Managers to ensure the timely execution of each stability study.
• Write, revise, and review SOPs and GMP documentation as needed.
• Perform QC analytical testing for GMP release and stability testing as needed
• Ensure timely submissions of reports to Quality Control
• Provide support and guidance in daily operations of quality Control and testing
• Develop project plans, develop and mange timelines, identify and respond to critical barriers
• pH Conductivity
• Osmolality testing
• Develop and support a system for managing test samples, reagents, and reference standards
• Report excursion/out of specifications results to the QC Departmental Supervisor/Manager
• Ensure lab is maintained (organized, clean, properly supplied)
• Perform other duties as assigned
• Analyze raw data, assess assay and system suitability criteria
• Follow safety procedures outlined in Chemical Hygiene Plan
• Excellent attention to detail