Sylvia Mcalister Email & Phone Number

United States

Mt. Gilead, North Carolina

Raleigh-Durham, North Carolina Area

Clayton, Nc

Change Control Specialist – Technical Transfer ProjectCorporate Change Control Board, Subject Matter Expert (SME) for the process. Evaluate process/procedure changes for manufacturing process. Monitor and report change management metrics to site leadership. Drive continuous improvement of change procedures/results by promoting consistency in the change control process.

Sanford, Nc

Championed continuous improvement projects for lean manufacturing practices. Subject Matter Expert (SME) for bacterial fermentation/purification process. Coordinated, reviewed, executed, tracked and ensured the compliance of all documentation/process changes, including the training material through SAP. Responsible for interaction with regulatory authorities regarding change controls, investigations and training revisions.

Marion, Nc

Ensured completion of all testing, including raw materials, in-process, final release, stability, and special project/protocol testing. Implemented and continuously improved quality systems to ensure compliance with testing Standard Operating Procedures and specification. Led laboratory audit-ready status efforts in understanding FDA, company, and other regulatory/quality requirements. Maintained a high level of expertise in current regulatory requirements and served as a laboratory resource for compliance to these requirements. Monitored testing techniques and reviewed accuracy of records and documentation generated

Bachelor Of Science (Bs), Chemistry

Activities and Societies: President of Student Affliates of the American Chemical Society (SAACS), 1993-95 Coordinated and Presided.

Bachelor Of Arts (B.A.), English Language And Literature/Letters