Job Title: Specialist Manufacturing(CAPA)
Location: Thousand Oaks, CA
Duration: 9+ Months
In the single use systems, resin and filter (SURF) category we have an open position for Specialist Manufacturing. The Specialist is expected to own deviations, CAPA, CAPA-EV, supplier investigations (SICAR & EN), change control and have metrics oversight responsibilities for records related to raw materials. Experience with managing multiple records is important and TrackWise user knowledge is an advantage.
May act as the External Supply Lead driving consistency across all Specialists in the space.
Will be required to communicate with many functions within the organization, facilitate development of solutions to critical business issues, and effectively define objectives to enable effective metric generation and reporting. There will be engagement both with Amgen internal stakeholders as well as our suppliers.
May serve as the primary point of contact between Site Plant Quality and the corporate Supplier Quality Management team to ensure the quality of raw materials used at the sites.
• Master’s degree and 4 years of Quality and/or Manufacturing experience
• Bachelor’s degree and 6 years of Quality and/or Manufacturing experience
• Associate’s degree and 8 years of Quality and/or Manufacturing experience
• High school diploma / GED and 10 years Quality and/or Manufacturing experience
• 6+ years related work experience (manufacturing, process development, or quality assurance) in in Biotech or pharmaceutical industry with progressively increasing responsibility and demonstrated experience in compliance, problem solving, advance root cause analysis, critical thinking, project management, and quality systems.
• Thorough understanding of quality management systems and quality control processes related to Raw Materials utilization in clinical and commercial operations.
• Thorough working knowledge of owning deviations, CAPAs, CAPA-EVs and change controls
• Demonstrated ability to work autonomously, present data in an organized and logical manner, and communicate effectively
• Demonstrated ability to navigate through ambiguity and provide a structured problem-solving approach.
• Excellent interpersonal relationship skills.
• Excellent oral and written communication skills.
• Proficient with Tracksides; MSWord; MS Excel; MS PowerPoint
• Ability to maintain remote working relationships with colleagues at other Amgen sites.
Top 3 Skills:
- Experience with owning multiple deviations, CAPA, CAPA-EV, supplier investigations (SICAR & EN), and change control
- Track Wise user knowledge
- Four years of Quality or Manufacturing experience