Ruth Williams

About Ruth Williams

Experienced Senior Leader with a demonstrated history of working in the health care…

Experience

1. Sr Quality Assurance Manager

   Alexion Pharmaceuticals, Inc.

   Jun 2022 — Present

   Creates, reviews, and approves design controls documentation for all phases of development • Provides compliance oversight per FDA 21CFR 820.30 and risk management files per internal SOP and ISO 14971. • Participates of project meetings and design reviews representing the quality function. • Provides quality engineering/quality assurance expertise in design controls, process controls, device CAPA, risk management, and design change controls critical to quality attributes. • Attention to details for resolving technical issues, quality issues, in compliance with Alexion QMS and regulatory expectations. • Lead root cause analysis investigations, statistical trend analysis for mitigations and actions to open deviations (non-conformances), change controls, and CAPAs. • Participates, reviews, and approves design review and audits design history files (DHF). • Quality Assurance support and SME for Medical Devices, combination products, and Finished product manufacturing to ensure compliance. • Oversight of continuous improvements and GMP systems related to Devices and Finished Product. • Works closely with internal cross-functional impacted areas to resolve open issues from record reviews and deviation events. • Reviewing of contractor documents i.e. protocols, deviations, and change controls to ensure compliance with Alexion procedures and standards • Support contract manufacturing organization audits • Monitors quality metrics pertaining to the process for device quality activities • Trends and analyses quality aspects to support continuous process improvements and risk mitigation. • Support Quarterly Management Review meetings, and leads team implementation of appropriate CAPAs • Reviews and assesses deviations and CAPAs; includes performing risk assessments, participating in root cause analysis investigations, tracking, follow-up, and reporting/trending and evaluating for effectiveness. • Supports Quality Assurance to guide various projects and technical meetings.

Education

• University of South Carolina

  Master's degree, Analytical Chemistry

  1989 — 1992

• Benedict College

  Bachelor of Science (BS), Chemistry

  1985 — 1989

Skills

• Quality Control
• Capa
• Validation
• Glp
• Quality Assurance
• Lims
• Training
• Gxp
• Analysis
• Management
• Quality System
• Standard Operating Procedure (Sop)
• Manufacturing
• Change Control
• Calibration
• Cleaning Validation
• Continuous Improvement
• Gmp
• Testing
• Fda
• Laboratory
• Sop