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Senior Associate Quality Complaints - Lab

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

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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 Quality Complaints - Lab

Live

What you will do

Lets do this! Lets change the world! The Senior Associate in Quality Assurance at Amgen plays a crucial role in maintaining high-quality standards across the manufacturing processes. They lead audits, address quality issues, develop training materials for QA procedures, and ensure compliance with both internal guidelines and external regulations.

Amgen is seeking a Sr. Associate Quality Complaints Product Complaints Return Lab, supporting the Product Complaints and Surveillance Team. The Product Complaints and Surveillance team owns and carries out the end-to-end global complaint process and management system, ensuring appropriate business connection across Amgen. In doing so, the focus is on assuring complaint processes and systems remain fully compliant through the quality operating standards and procedures to current, emerging internal and external requirements. In addition, the team translates information from the market to drive continuous improvement.

The Sr. Associate evaluates complaint related return unit samples. Maintains the product complaint laboratory in compliance with Good Laboratory Practices (GLP). Performs work in a manner consistent with GLPs. Executes day to day operations in the product complaint laboratory and ensures the daily workload is completed efficiently and with high quality (e.g. PMs, calibrations, and general servicing).

Key Responsibilities:

  • Applies analytical skills to evaluate product complaint return samples using multiple sources of information

  • Manages work in accordance with Good Laboratory Practices (GLPs)

  • Interprets SOP requirements

  • Identifies product quality and safety risk with product complaint return samples

  • Provides technical advice on complaint investigations

  • Provides subject matter experts assessments (Return Unit Inspections)

  • Partners with FPT on return sample evaluations, establishing inspection criteria and inspection method.

  • Performs return inspection for complaints

  • Supports product security inspections as needed

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 employee with these qualifications.

Basic Qualifications:

Masters degree OR

Bachelors degree and 6 months of Quality experience OR

Associates degree and 2 years of Quality experience OR

High school diploma / GED and 4 years of Quality experience

Preferred Qualifications:
  • Quality and manufacturing experience in biotech or pharmaceutical industry

  • Bachelors Degree in a Science Field

  • Ability to successfully manage workload to timelines

  • Familiarity with basic project management tools

  • Demonstrated ability to consistently deliver on-time, and high-quality results

  • Ability to operate in a matrixed or team environment

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
US

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