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Sr Specialist Supply Chain QA

Employer
Amgen
Location
Thousand Oaks, California
Start date
Jun 8, 2024

Job Details

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.

Senior Specialist Supply Chain QA

Live

What you will do

Lets do this! Lets change the world!

Provide Quality Assurance strategic collaboration with global distribution and supply chain leaders. Ensure compliance to GMP regulations for area operations and associated processes, including warehousing and distribution, inventory management, and management of external relationships with Logistics Service Providers like storage depots and transportation service providers.

Typical tasks include:

  • Partner with Supply Chain leaders to develop clinical supply chain future strategy.

  • Assess product distribution risks and develop post-distribution inventory control plans in response to emergent quality defects identified through internal deviations, external complaints or clinical site events.

  • Provide veteran QA guidance for supply chain teams executing transformation initiatives, including integrations following mergers and acquisitions, supply chain improvement projects, novel clinical trial designs and distribution expansion initiatives.

  • Internal Quality Assurance support for GMP warehouse and inventory management operations

  • Support high risk investigations/deviations

  • Internal Quality Assurance support for creation and revision of GMP procedures and record generation, including document review, approval, and archival

The successful candidate will have experience working in multiple GMP databases

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:
  • Doctorate degree and 2 years of quality, supply chain or distribution experience OR

  • Masters degree and 4 years of quality, supply chain or distribution experience OR

  • Bachelors degree and 6 years of quality, supply chain or distribution experience OR

  • Associates degree and 10 years of quality, supply chain or distribution experience OR

  • High school diploma / GED and 12 years of quality, supply chain or distribution experience

Preferred Qualifications:
  • 3+ years of experience in a Quality Assurance role supporting GMP operations

  • Strategic vision and collaborative attitude to develop business balanced and compliant supply chain strategies

  • Previous experience with quality system transactions (SAP, LIMS, Trackwise, Veeva)

  • Strong technical writing skills, demonstrated experience creating deviation technical assessments or equivalent

  • Demonstrated ability to perform GMP operations including following detailed SOPs, maintaining training, and adhering to good documentation practices.

  • Educated in a science field with 5 years of experience in GMP/GCP operations or similarly regulated industry

  • Proficient with database use, including data input, archival, and query retrieval

  • Great attention to detail and high degree of accuracy in task execution and GMP documentation

  • Highly effective verbal and written communication skills, strong interpersonal skills

  • Ability to complete tasks autonomously, provide updates to area manager, and identify potential issues

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.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

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
US

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