Grace M. Fontánez Santana

Front Line Manager – 2nd Shift | Lines L319, L548, 304 & Share Crew

• Lead and manage multiple production lines, including blister packaging (Line 304), device packaging (Lines L319 and L548), and shared support crew operations.
• Ensure compliance with current Good Manufacturing Practices (cGMP), and applicable regulatory standards across facilities, equipment, processes, and documentation.
• Oversee production planning and execution to meet quality, safety, and supply objectives.
• Identify, assess, and mitigate risks to ensure product safety, purity, quality, and effectiveness.
• Conduct and manage staff performance evaluations as part of the MAP (Managing Amgen Performance) process, fostering goal alignment, and professional development.
• Lead and support continuous improvement initiatives, including 5S, Standard Work, and Overall Equipment Effectiveness (OEE) improvements.
• Collaborate cross-functionally, and coach teams on best practices to drive engagement and alignment with Amgen’s mission.
• Champion a positive work culture by reinforcing Amgen’s core values, and motivating teams to recognize their individual impact, and contribute with excellence.

Specialist Manufacturing – Deviation Team | AML 1, AML 14, AML 23, Site AML

• Lead robust investigations for major deviations and trend investigation records supporting Inspection and Packaging Operations (AML 1), Filling Operations (AML 14), and site-wide AML investigations.
• Support troubleshooting efforts to identify causal factors, and implement corrective actions.
• Evaluate manufacturing procedures and training requirements to identify technical gaps and process improvement opportunities.
• Facilitate and lead strategic meetings, such as RCA, TA Monitoring Sessions, and the AML 1 Investigation Advisory Board Forum, ensuring adherence to SOPs and investigation standards.
• Act as the main presenter for AML 1 deviation and trend topics during regulatory inspections and audits (e.g., FDA), demonstrating strong communication and facilitation skills across all organizational levels.
• Support monthly business metrics analysis, and contribute to performance reviews and decision-making through data-driven insights.
• Trained in System Thinking Analysis through Amgen’s internal development program, enhancing my ability to evaluate complex manufacturing systems holistically, identify interdependencies, and drive strategic improvements aligned with Mistake Proofing principles.

Sr Associate Manufacturing – Minor and Major Deviations Lead | AML 1 & Packaging Operations

• Lead documentation of minor deviation records to support Inspection and Packaging Manufacturing Operations, ensuring compliance with cGMP and regulatory standards.
• Drive complex major deviation investigations related to inspection and packaging processes, applying root cause analysis to identify systemic issues and corrective actions.
• Facilitate strategic meetings such as Triage Sessions, Major Deviation Weekly Reviews, and RCA workshops with suppliers to ensure alignment with deviation procedures and investigation standards.
• Develop and maintain Smartsheet dashboards to monitor business performance, compliance metrics, and error prevention initiatives, supporting data-driven decision-making.