Alison Schmidt Email & Phone Number

Holly Springs, NC, US

Direct the Global Clinical Supply Quality team for all CSL product platforms including Gene Therapy, Vaccines, Recombinant, and Plasma.

Responsible for a multi-disciplinary team including managers and senior professionals providing frontline Quality Assurance oversight of third party GMP sterile vaccine clinical trial packaging and batch disposition of clinical trial material (CTM) globally to ensure compliance with applicable regulatory filings, cGMP regulations and data integrity, and.

Holly Springs, North Carolina, United States

Holly Springs, North Carolina

Aiken, SC

Lead a team of quality assurance associates responsible for Supplier Quality, Consumer Complaints, Product Release, Deviation and CAPA management, Periodic Product Review, Quality Council, TrackWise Administration, Recall, Field Alert and Inspection Readiness. Provided sound judgment to set unambiguous and compelling vision for team that contributes to.

Aiken, SC

Manage, maintain and enhanced the current site documentation control practices and resources including managing of 2 documentation coordinators and a compliance technician. Serve as site market liaison in the development and maintenance of the following: Technical Terms of Supply, Quality Agreements, Regulatory Registration and Conformance files, Review.

Support production of flu, meningitis, yellow fever and diphtheria/tetanus vaccine by ensure completion of the annual supplier audit schedule by performing quality audits of key raw material and component supplier and contract partners. Respond to quality issues by performing for cause audits. Communicate findings to internal user groups and quality.

Manage product quality and compliance for assigned contractors (3rd party). Ensure that quality aspects are built into Quality Agreements and periodically review and revise to meet continuous quality improvement. Advisor to the department as resident Microbiologist on microbiologic issues. Critically evaluate reports, processes and facilities against.

Gained cGMP and knowledge for consumer product testing of microbial contamination of finished product, intermediate product and raw material. Acquired proficiency in LIMs. Supervision of technicians in the testing laboratory to assure completion of incoming test samples and preparation of media. Perform sanitization swabbing for cleaning validation and.

Bachelor Of Science - Bs, Microbiology, General

Bs, Microbiology

Undergraduate Research Assistant, University of Tennessee, Aquatic Ecology Laboratory, Knoxville, TN, Spring 2000. The project involved.