Senior Associate Quality Complaints

3 weeks ago


Thousand Oaks, United States Amgen SA Full time

HOW MIGHT YOU DEFY IMAGINATION? You’ve 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 mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s 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 Let’s do this Let’s 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:

Master’s degree OR Bachelor’s degree and 6 months of Quality experience OR Associate’s 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

Bachelor’s 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.

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