Pamela Eastman Email & Phone Number

West Lebanon, New Hampshire

9 Technology Drive, West Lebanon, New Hampshire

• Managed exceptions, CCAs, CAPA investigations and CHOs, compiling data and reporting trends in support of deviations and process improvements. Supported Directors with review of process data packages and documentation..
• Originated and revised quality documentation. Reviewed completed documentation for quality assurance.
• Maintained metrics spreadsheets designed to track process steps and performance. Analyzed data to present to management.
• Provided support during regulatory audits for FDA, EMA, and ISO. Performed internal quality audits to ensure that the department was audit ready at all times.
• Created and managed the department specific process and production schedules.
• Developed and maintained schedules for equipment cleaning effectiveness monitoring requirements.

9 Technology Drive, West Lebanon, New Hampshire

• Lead technician responsible for training technicians in the protein purification process and associated quality systems. Recognized for accuracy and quality work, setting high standards, and strong teamwork leading to.
• Responsible for managing the schedule for solutions used in the manufacturing process.
• Documented comments and deviations and assisted in the process of closing deviations within 30 days. Compiled data and reported process trends to supervisor.
• Assisted with troubleshooting of equipment or methods, investigating and resolving issues during process manufacturing. Responsible for coordinating, scheduling and performing maintenance of equipment used in the.
• Worked closely with Engineering and Validation to test and validate new equipment, participating in FAT (factory acceptance testing) and SAT (site acceptance testing).

9 Technology Drive, West Lebanon, New Hampshire

• Hands-on protein purification manufacturing, including solution formulations, with the responsibility of training others on a majority of protocols.
• Lead media/buffer lab technician, providing media/buffer formulation training to purification technicians while learning the purification process.
• Collaborated with supervisor to implement a solution hold study program that allowed for a consistent approach to solution expiry dating.
• Prepared, revised and created documentation associated with the manufacturing process.
• Supported the Manufacturing Sciences department with coordination of process/equipment improvements, in-process testing, and product development activities.