Michele Pierce Email and Phone Number

•Manage multiple client accounts while maintaining high quality standards within current Good Manufacturing Practices (cGMPs)•Interpret and understand clinical research manufacturing and packaging protocol specifications•Communicate effectively with pharmaceutical companies, vendors, and internal departments to transfer project details, compose schedules and resolve conflict•Assemble and generate packaging assembly records and business quotations•Procure components utilizing a master planning order to ensure the timely arrival and availability of material for project need•Maintain inventory levels of bulk items and finished product based on projected protocol need•Develop and coordinate distribution project needs for accurate and controlled shipment of products

•Manage multiple client accounts while maintaining high quality standards within current Good Manufacturing Practices (cGMPs)•Interpret and understand clinical research manufacturing and packaging protocol specifications•Communicate effectively with pharmaceutical companies, vendors, and internal departments to transfer project details, compose schedules and resolve conflict•Assemble and generate packaging assembly records and business quotations•Procure components utilizing a master planning order to ensure the timely arrival and availability of material for project need•Maintain inventory levels of bulk items and finished product based on projected protocol need•Develop and coordinate distribution project needs for accurate and controlled shipment of products

•Managed and led packaging operations on the production floor. Supervised 30 employees on a daily basis.•Assisted in the scheduling of rooms and future projects.•Trained employees on Standard Operating Procedures (SOPs) and cGMPs•Performed HR duties for employees including Annual Reviews and Corrective Action Reports.

•Generated and approved Electronic Batch Records post packaging. Assured clinical trial packaging complied with federal cGMP parameters within the company SOPs Delivered EBR to client and responded to any observations. Liaison between internal and external customers, focused on addressing customer needs and meeting their requirements Released lots for distribution after receipt of client approval.•As needed, performed inspections during the production, packaging and labeling of clinical trials.

•Performed inspections during the production, packaging and labeling of clinical trials.

•Performed inspections during the production, packaging and labeling of clinical trials.