6 days old

Senior Specialist External Supply

Amgen
Thousand Oaks, CA 91360
  • Job Code
    121956178
Amgen

Job ID: R-102327
Location: Thousand Oaks, CA, US 91360
Additional Location: US - Puerto Rico - Juncos

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 and driving activities to meet key performance metrics.

The Senior Specialist owns, investigates and acts as first responder to deviations from the manufacturing sites and leading activities on the quality records with suppliers.

Responsibilities:
  • Addresses and expedites 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, packaging process, or specifications based upon trend, deviation, and related analyses.
  • Maintains unified 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.


Basic Qualifications

Doctorate degree and 2 years of Quality and/or Manufacturing experience

OR

Master's degree and 4 years of Quality and/or Manufacturing experience

OR

Bachelor's degree and 6 years of Quality and/or Manufacturing experience

OR

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

OR

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

Preferred Qualifications

  • 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.


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.



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Posted: 2020-07-28 Expires: 2020-08-28

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Senior Specialist External Supply

Amgen
Thousand Oaks, CA 91360

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