What you will do
Let’s do this. Let’s change the world. In this vital role you will conduct low to medium complexity complaint investigations and determines if complaint investigations require customer concern for further investigation.
Evaluates and ensures triaged product complaint records align with applicable procedures
Evaluates and owns complaint records with basic investigations
Ensures quality of complaint records
Completes assigned assessments per applicable procedures
Applies analytical skills to evaluate complex situations using multiple sources of information
Drives the complaint process per SOP requirements
Owns or manages the review/approval process flow in CDOCS of controlled documents; while adhering to format, content, and style guidelines, considering usability, and ensuring accuracy, consistency, and quality according to templates and style guide
Supports management of assigned projects or project tasks to achieve agreed deliverables within time and with expected quality, including (but not limited to) proactive written / in person communication, status updates, tracker & tool maintenance
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.
Basic Qualifications:
Master’s degree and 1 to 3 years of Quality experience OR
Bachelor’s degree and 3 to 5 years of Quality experience OR
Diploma and 7 to 9 years of Quality experience
Preferred Qualifications:
Quality and/or manufacturing experience in biotech, medical device or pharmaceutical industry
Bachelor’s Degree in a Science Field
Leadership skills
Ability to successfully manage workload to timelines
Familiarity with basic project management tools
Ability to operate in a matrixed or team environment with site, functional, and senior management leadership
Experience in driving decision making by using the DAI principles
Understanding of quality and industry requirements/expectations of a QMS
Understanding of the applicable manufacturing/testing processes (i.e., API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)
Ability to negotiate a position after taking feedback from multiple sources
Demonstrated ability to lead functional teams, consistently deliver on-time, and high-quality results
Ability to translate business and collaborator feedback and requirements into accurate and efficient processes using clear language and format
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
اطلب مساعدة الخبراء لكتابة سيرة ذاتية مميزة.