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Sr. Associate MCS Major Deviations

Employer
Amgen
Location
Thousand Oaks, CA
Start date
Sep 27, 2022
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Job Details

The Senior Associate will be a member of the team that investigates Deviations in the Amgen Thousand Oaks Development Supply Chain Organization, including Drug Substance and Drug Product manufacturing, Supply Chain, Drug Product Assembly/Packaging, and Warehouse Operations. These investigations are compliant with regulatory requirements and include determination of scope, product impact, root cause, and effective corrective/preventative actions (CAPAs). This individual will play an integral role collaborating within a cross-functional team that includes Manufacturing, Quality, Process Engineering, Process Development, Analytical Sciences, Quality Control, Supply Chain, and Regulatory Affairs.

The selected individual will:

  • Manage deviation investigations, including establishing investigation teams, leading root cause analysis, development of CAPAs, and compliant documentation of all findings.
  • Present investigations to regulatory inspectors and internal auditors
  • Clearly communicate investigation progress to impacted areas and leadership

Desired skills/behaviors include:

  • Ability to coordinate and effectively lead cross-functional teams through complex investigations, and complete milestones on-schedule.
  • Ability to build effective relationships across functions.
  • Demonstrated ability to quickly understand and clearly communicate complex issues
  • Negotiation skills when working with internal team members.
  • Navigate through ambiguity and provide a structured problem-solving approach.
  • Clear and concise technical writing

Basic Qualifications

  • Masters degree Or
  • Bachelors degree and 2 years of Manufacturing or Operations experience Or
  • Associates degree and 6 years of Manufacturing or Operations experience Or
  • High school diploma / GED and 8 years of Manufacturing or Operations experience

Preferred Qualifications

  • 4+ years related work experience (manufacturing, process development, or quality assurance) in biotech or pharmaceutical industry with progressively increasing responsibility
  • Excellent written and verbal communication skills, ability to work in a team matrix environment and build relationships with partners
  • Strong interpersonal skills
  • Experience with problem-solving, root cause analysis, critical thinking, and quality systems.
  • Experience using TrackWise for Deviation investigations and CAPAs
  • Degree in Science or Engineering
  • Demonstrated project management ability

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.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.

Company

We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.

We live the mission.

We win together.

We thrive on continual challenge.

Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.

At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.

Connect with us to explore how you can Win, Live, and Thrive at Amgen.

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Find Us
Website
Phone
805-447-1000
Location
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States
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