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Sr. Associate: MCS Investigations Team

Employer
Amgen
Location
Thousand Oaks, California
Start date
Feb 24, 2024

Job Details

HOW MIGHT YOU DEFY IMAGINATION?

Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Senior Associate Manufacturing - MCS Investigations Team

Live

What you will do

Lets do this. Lets change the world.

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 achievements 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

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.

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

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

  • Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

  • Stock-based long-term incentives

  • Award-winning time-off plans and bi-annual company-wide shutdowns

  • Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your 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.

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

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