Heidi Stevens Email & Phone Number

New Mexico, United States

  Development of Project Scope, monitoring deliverables and re-enforcing goals  Secured supplies cross functionally with supply chain and procurement  External communication partners, Schedule Timeline maintenance and implementation, Contract service proposal, invoicing objectives deliverables. Quality Assurance Documentation and data analysis coordination establishment of protocol Internal and external Facility Audit establish quality agreements between partners Risk mitigation development for new and existing partnerships. Assessment of implementation of innovation and growth to match business needs.

United States

 Lead for quality forums and governances for master batch record review, creation, change controls, and tech transfer of new clinical and commercial molecules.  Provide feedback and coaching to commercial and clinical development that creates a collaborative environmental enhanced unit performance and integration across functional departments. Develop, maintain, and act upon quality key performances indicators. Inspection response and CAPA team member, responsible for supporting internal audits and global Health Authority inspections. Quality reviewer and approver for investigation records and CAPA records, including medium and high-risk events. Team lead for material defect reduction project, aimed at improving the response and vendor CAPA for leaks and other material defects identified during incoming QC release.  Function as delegate for Quality Assurance Operations senior manager, as needed, in department and project meetings.

Massachusetts, United States

 Provide Quality Assurance oversight of cGMP operations in the Single use facility Building Review of manufacturing batch records (MBRs) and documents for Lot release of drug substance  Author, review and implement site standard operating procedures (SOPs), in accordance with global corporate procedures and cGMP regulatory guidance. Provide Quality oversite and guidance for atypical events in operations Review, approve, and provide oversite for quality master data.

Devens, Massachusetts

Lexington Ma

- Experience with New MFG start-up for Human enzyme replacement therapy disposal Bioreactor process. - Experience in the manufacturing process of media’s, buffer solutions and cell culture with inoculation/bioreactor/recovery process• Lead peer and technical training for Nova maintenance, cell culture monitoring, production schedule operations and Safety • Assist with updating and revising Standard Operating Procedures (SOPS) and Batch Records creation/review• Direct involvement in the commissioning and validation of manufacturing equipment • Schedule and coordinate project activities for new drug substance and process improvement• Implemented various cross training processes for 3rd shift• Perform maintenance and functional standardization on manufacturing bench top equipment

Portsmout Nh

• Updated and revised SOPs and training material• Performed monthly and annual audits: payroll, travel expenses, contractor services and projects repair of process and manufacturing equipment maintance.• Maintained current data SAP involving invoicing, check • Track wise trained• Requested certifications of conformance compliance from vendors