Specialist Quality Assurance - Drug Product

Role Summary

Specialist Quality Assurance - Drug Product is responsible for daily oversight of aseptic Drug Product manufacturing operations at Amgen, Thousand Oaks, providing compliance oversight to Manufacturing and Facilities & Engineering, and supporting the implementation and use of quality systems. Duties include ensuring timely delivery and completion of records within the Quality Management System (Deviations, CAPAs, Change Controls, etc.); SOP revision, review and approval, and work order approval. The Specialist will also support tech transfers into the facility, evaluate compliance issues, provide recommendations, and assure progress of quality records to completion. The individual will represent the B20 Quality function on projects necessary to achieve departmental and plant goals and will work in a dynamic cross-functional environment.

Responsibilities

• Provide Quality support to Tech Transfers into the Drug Product facility.
• Provide Quality Oversight of the manufacturing facility including manufacturing operations, testing, inspection and utilities.
• Participates in and provides quality oversight for quality records including Deviations, Change Controls, and CAPAs, assuring adherence to procedural requirements and regulatory expectations.
• Perform impact assessments as part of change controls impacting production or QA processes.
• Provides quality expertise and guidance to operational staff and within cross functional Amgen teams.
• Reviews and approves controlled documents, including but not limited to Standard Operating Procedures, Protocols and Reports.
• Ensures that operations align with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls.
• Contribute to and drive continuous improvement projects in cross-functional collaboration.
• Represent the Quality function and provide quality oversight during the implementation of projects required to improve and deliver our departmental and manufacturing plant goals.
• Contribute to and drive digital innovation solutions and applications in cross-functional collaboration.
• Supports or leads Inspection Readiness for the facility. Participates in internal/external audits and inspections and may directly interact with regulatory agencies during on-site inspections.

Qualifications

• Required: Doctorate degree
• Required: Master’s degree and 2 years of quality experience
• Required: Bachelor’s degree and 4 years of quality experience
• Required: Associate’s degree and 8 years of quality experience
• Required: High school diploma / GED and 10 years of quality experience
• Preferred: Bachelor’s Degree in Science
• Preferred: 5 plus years of aseptic processing experience in QA or Manufacturing
• Preferred: Excellent interpersonal, verbal and written communication skills with all levels within the Organization; strong level of analysis skills to evaluate and interpret information to arrive at logical and quality-minded conclusions.
• Preferred: Experience applying problem-solving tools for root cause analysis.
• Preferred: Strong leadership capabilities and proven experience applying GMP requirements in an operational setting
• Preferred: Ability to independently interact with various levels, drives tasks to completion, and is a self-starter.
• Preferred: Applies project management principles and techniques.