Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. 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. Become the professional you are meant to be in this meaningful role.

Manager, Quality Assurance

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will hire, train, develop, and manage Quality Assurance professionals to successfully deliver on role to support GMP Manufacturing and to manage change in an effective, efficient and compliant manner.

This individual will be responsible for shift 4 and 5.

Shift 4 starts from 7 am until 7 pm on Saturdays, Sundays, Mondays; Shift 5 starts from 7 pm to 7 am on Saturday, Sundays, Mondays. New hire will work hours depending on need.

Additional Responsibilities:

• Independently determine approach to managing daily operations; guided by general policies and management mentorship

• Develop or contribute to the development of procedures and standards by which others will operate.

• Interpret and execute standards and procedures directly affecting work activities

• Develops and communicates goals and objectives to staff and key partners

• Supervise goal performance and coordinate action for improvement of shift and overall PQA performance by championing department OPEX efforts. Assist project teams in prioritizing, project timelines and in securing resources.

• Actively represent Quality Assurance on incident triage teams or support efforts by providing mentorship and/or technical leadership

• Partner with internal personnel at various management levels to resolve issues, establish direction, acquire resources, and drive change

• Reviewing and approving operational procedures and product manufacturing procedures, approving process validation protocols and reports for manufacturing processes, and approving environmental characterization reports and change control documents.

• Approving non-conformances, representing QA on project teams and approving change-over completion controls.

• Leading investigations, as well as leading plant and site audits.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The outstanding professional we seek is a candidate with these qualifications.

Basic Qualifications:

Doctorate degree

OR

Master’s degree and 3 years of Quality experience

OR

Bachelor’s degree or and 5 years of Quality experience

Or

Associate’s degree and 10 years of Quality experience

Or

High school diploma / GED and 12 years of Quality experience AND 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications:

• Bachelor’s Degree in Life Sciences, Engineering or related field

• 6 + years of quality assurance or combination of quality and manufacturing experience in the biotechnology/pharmaceutical industry

• 3 + years of supervisory/management experience

• Experience in areas of manufacturing, investigations, CAPA, product release, validation and/or change control

• Experience in regulations, standards and guidelines that apply to biotech manufacturing in a multi-product environment

• Ability to develop meaningful team and staff goals, manage performance and coach and develop staff

• Ability to manage to established timelines and deliver results to meet or exceed department and company goals and objectives.

• Thorough knowledge of monoclonal antibody manufacturing or ability to apply previous biotech manufacturing knowledge to understand manufacturing deviations

• Ability to communicate clearly, facilitate discussions and present to audiences at all levels of a site organization

• Decisive and independent risk-based decision-making ability on the floor to support manufacturing needs

Thrive

Some of the vast rewards of working here

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.

• Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey

• A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

• Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now

for a career that defies imagination

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

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