S. S. James

About S. S. James

Specialties: Expert in FDA product safety guidelines and requirements governing pre and post marketing adverse event reporting.

Experience

1. Manufacturing Process Engineer Manager

   Pfizer

   Nov 2021 — Present · Sanford, NC, US

   Designed and implement comprehensive training programs to support staff development and promote best practices, driving continuous learning and improvement throughout the organization. Developed and executed clear objectives for a diverse team, managing multiple complex projects and cross-functional work activities while maintaining strict control over timelines and budgets. Drove audit readiness initiatives and represented Technical Operations in manufacturing audits, ensuring full compliance with industry standards and driving excellence in operations. Facilitated strong communication and collaboration between management, production staff, and other departments, fostering a positive and productive work environment. Instilled accountability throughout the value stream, ensuring delivery of key performance indicators for safety, quality, service, and cost in line with site goals and objectives, and driving continuous improvement efforts. Conducted reviews of manufacturing batch records, maintaining strict adherence to operational standards and best practices. Monitored and directed the efforts of a team of subordinates to achieve short-term and mid-term goals, leveraging strong leadership and motivational skills to drive results. Liaised with core support groups to expedite the resolution of recurring system issues, ensuring uninterrupted operations. Authored and approved quality and safety investigations, implementing necessary Corrective Action and Preventative Actions to drive operational excellence. Utilized advanced Continuous Improvement (CI) tools to drive continuous improvement and innovation within the organization. Led a high-performing, dynamic, and multifunctional team, providing exceptional operations support and driving strong business outcomes

Education

• Villanova University

  Six Sigma Certificate, Quality/Manufacturing Process

  2016 — 2016

• Albert Einstein College of Medicine

  Internship, Microbiology

  2008 — 2008

• Purchase College, SUNY

  BS, Biochemistry

  1999 — 2003

• Hunter College

  MA, Molecular Genetics / Neuroscience

  2007 — 2008

Skills

• Document Compliance
• Process Science
• Documentation
• Laboratory Information Management Systems (Lims)
• Cgmp
• Life Sciences
• Word
• Gx Pharma
• Bioassays and Immunogenicity
• Investigations
• Pharmacovigilance
• Quality Control
• Gmp
• Sop
• Fda
• Audit
• Glp
• Change Control
• Hplc
• Six Sigma
• Capa
• Clinical
• Compliance
• Cell Based Assays
• Writing
• Sds-Page
• Document Management
• Data Management
• Powerpoint
• Validation
• Technical Writing
• Clinical Trials
• Elisa
• Biochemistry
• Excel
• Microsoft Office
• Lims
• Testing
• Quality Assurance
• Auditing