Day to Day Responsibilities:
- Understand Amgen’s mission and strategy
- Understand and meet with key stakeholders
- Complete necessary systems training
- Ability to start owning investigations and Quality records
- The Senior Specialist External Supply will be responsible for managing and executing total quality management systems for the External Supply organization (Raw Materials Categories, Devices, and Contract Manufacturing)
- The Senior Specialist is expected to execute nonconformance, CAPA, CAPA-EV, SICAR, EN, Change Control and metrics oversight responsibilities.
- May act as the External Supply Lead driving consistency across all Specialists in the space.
- The Senior Specialist processes, investigates and acts as first responder to deviations.
- Addresses and expedites product deviation under the company's quality management system procedures, and ensures compliance with regulatory agencies. Monitors, investigates deviations and determines corrective and preventive actions to appropriate company authorities to modify existing manufacturing or packaging process based upon trend, deviation, and related analyses.
- Maintains unified product defect investigation operating procedures.
- Provides technical expertise to optimize deviations management, corrective and preventive actions effectiveness, and prevent re-occurring events.
- Maintains and monitors systems to ensure that all deviations received are appropriately investigated and concluded per the company's quality standards and procedures.
- Communicate with all levels of the organization, facilitate development of solutions to critical business issues, and effectively define objectives to enable effective metric generation and reporting.
- 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.
- May develop work force model criteria to support business initiatives for the department needs
Self-starter, works independently, corporate professional that can navigate at all levels of organization and with external suppliers, objective and the ability to manage root cause investigations and corrective actions in a timely manner, good communication skills (live discussions, emails, presentations, etc), good story telling skills to appropriately document investigations and follow up in Quality Management Systems, flexible and comfortable working with ambiguity, can manage multiple priorities with deadlines, knows when to escalate issues, has an Amgen-first mindset but can also represent suppliers to the internal org, knowledge of the biopharm manufacturing process, knowledge of the drug commercialization process, knowledge of GXPs, understands a regulated environment, patient first mentality, Quality mindset, self-awareness, works well in cross-functional teams
Doctorate degree and 2 years of Quality and/or Manufacturing experience
Master’s degree and 6 years of Quality and/or Manufacturing experience
Bachelor’s degree and 8 years of Quality and/or Manufacturing experience
Associate’s degree and 10 years of Quality and/or Manufacturing experience
High school diploma / GED and 12 years Quality and/or Manufacturing experience
- Experience/success in managing investigations in a technology field (preferably biotech or pharm)
- Experience in working in a matrixed environment
- Experience working for a global company and can appreciate diversity, different cultures and time zones
- Experience working with global sites
- Experience in Manufacturing and/or Quality
Years of experience/education:
- Bachelors in biotech, science, engineering, etc;
- 4-6 years experience in Manufacturing and/or Quality
"This posting is for Contingent Worker, not an FTE"
- 8+ 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 EU and US cGMPs regulations
- Demonstrated ability to work autonomously, present data in an organized and logical manner, and communicate effectively
- Demonstrated ability to coordinate and lead cross-functional project teams and deliver on schedule.
- Demonstrated ability to navigate through ambiguity and provide a structured problem-solving approach.
- Experience in defending processes, procedures, and decisions during regulatory inspections.
- Organizational savvy and presence to build effective relationships across functions.
- Excellent interpersonal relationship skills.
- Excellent Technical Oral and written skills, ability to write/evaluate investigation responses to comply to regulatory requirements.
- Operational Excellence skills with Root Cause Analysis, and Structured Problem Solving
- Proficient with MSWord; MSExcel; MSPowerPoint; MSVisio; MSProject, Trackwise
- Demonstrated ability to deliver results through living the Amgen values.
- Negotiation skills when working with external suppliers and internal team members.
- Ability to maintain remote working relationships with colleagues at other Amgen sites