Shadi (Sage) Privett

Quality Specialist for sterile-fill pharmaceutical manufacturing performed in a class 100 aseptic cleanroom environment in accordance with FDA and EMA regulations.

• Conducted routine quality inspections of manufacturing areas and processes for SOP adherence.
• Performed deviation investigation utilized root cause analysis techniques.
• Achieved timely resolution of non-conformance issues by implementing corrective action and preventative action plans working closely with relevant departments.
• Enforced safe working practices, particularly with Highly Potent and Cytotoxic products.
• Qualified Trainer, capable of performing and documenting on-the-job and awareness training.
• Subject Matter Expert (SME) in glass washing operations.
• Maintains In-Process Inspection qualifications for components and finished products.
• Review lot-related paperwork, logbooks, and other controlled documentation following GDP, cGMP and ALCOA+ principles.
• Trained in setup, use, teardown, and troubleshooting of filling equipment.
• Assess risks associated with manufacturing activities in a collaborative cross-department unit.
• Records and tracks lot-related data.
• Perform archiving of controlled documents.

Operator for Ceramic small-parts assembly and quality control in an ITAR facility across multiple production lines.

• Operated UV systems and assembly equipment to produce electronic components.
• Conducted quality inspections to ensure adherence to production standards.
• Collaborated with team members to streamline assembly processes and improve workflow.
• Trained new operators on safety protocols and PPE requirements.
• Cross trained in different stations to provide optimal coverage and meet production goals.
• Record batch information both digitally and electronically following ALCOA++ principles
• Followed safe handling and disposal techniques for hazardous waste.