Quality Record Owner for External Supply - Devices / Secondary Packaging

The Manufacturing Specialist External Supply will be responsible for managing and executing total quality management systems for the External Supply organization (Devices and Secondary Packaging).

This Specialist is expected to execute Major/Minor Deviation, CAPA, CAPA-EV, SICAR, EN, Change Control and metrics oversight responsibilities.

Responsibilities:

• Process, investigate and act as first responder to deviations.
• Address and expedite product deviation under the company's quality management system procedures and ensures compliance with regulatory agencies.
• Monitor, investigate deviations and determine corrective and preventive actions to appropriate company authorities to modify existing manufacturing or packaging process based upon trend, deviation, and related analyses.
• Provide technical expertise to optimize deviations management, corrective and preventive actions effectiveness and prevent reoccurring events.
• Maintain and monitor 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 External Supply Quality Management team to ensure the quality of raw materials used at the sites.
• May assist in the development of work force model criteria to support business initiatives for the department needs.

Basic Qualifications

Doctorate degree

OR

Master's degree and 3 years of External Supply / Quality / Manufacturing experience

OR

Bachelor's degree and 5 years of External Supply / Quality / Manufacturing experience

OR

Associate's degree and 10 years of External Supply / Quality / Manufacturing experience

OR

High school diploma / GED and 12 years of External Supply / Quality / Manufacturing experience

Preferred Qualifications

• 6+ years related work experience (manufacturing, process development, or quality assurance) in Biotech or pharmaceutical industry with demonstrated experience in compliance, problem solving, advance root cause analysis, critical thinking, project management, and quality systems.
• 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 with minimal supervision, 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.
• Able to defend 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 with regulatory requirements.
• General understanding of Operational Excellence skills with emphasis on Root Cause Analysis
• 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.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.