The Manager Quality Assurance 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 and Shift 5 starts from 7 pm
until 7 am, Saturday-Monday. New hire will work hours depending on
- Independently determine approach to managing daily operations;
guided by general policies and management guidance
- 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
- Monitor goal performance and coordinate action for improvement
of shift and overall PQA performance by championing department OPEX
efforts. Assist project teams in establishing priorities, project
timelines and in securing resources.
- Actively represent Quality Assurance on incident triage teams
or support efforts by providing guidance and/or technical
- Partner with internal personnel at various management levels to
resolve issues, establish direction, obtain resources, and drive
- 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
- Approving non-conformances, representing QA on project teams
and approving change-over completion controls.
- Leading investigations, as well as leading plant and site
Master's degree and 3 years of Quality experience
Bachelor's degree or and 5 years of Quality experience
Associate's degree and 10 years of Quality experience
High school diploma / GED and 12 years of Quality experience
2 years of managerial experience directly managing people and/or
leadership experience leading teams, projects, programs or
directing the allocation of resources
- Bachelor's Degree in Life Sciences, Engineering or related
- 6 + years of quality assurance or combination of quality and
manufacturing experience in the biotechnology/pharmaceutical
- 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
Ability to build strong and collaborative partnerships with
client groups and influence changes in practices to ensure
Amgen is committed to unlocking the potential of biology for
patients suffering from serious illnesses by discovering,
developing, manufacturing and delivering innovative human
therapeutics. This approach begins by using tools like advanced
human genetics to unravel the complexities of disease and
understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages
its expertise to strive for solutions that improve health outcomes
and dramatically improve people's lives. A biotechnology pioneer
since 1980, Amgen has grown to be one of the world's leading
independent biotechnology companies, has reached millions of
patients around the world and is developing a pipeline of medicines
with breakaway potential.
If you're seeking a career where you can truly make a difference
in the lives of others, a career where you can work at the absolute
forefront of biotechnology with the top minds in the field, you'll
find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers
innovative human therapeutics. Our medicines have helped millions
of patients in the fight against cancer, kidney disease, rheumatoid
arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life
for people around the world, Amgen fosters an inclusive environment
of diverse, ethical, committed and highly accomplished people who
respect each other but compete intensely to win. Together, we live
the Amgen values as we continue advancing science to serve
Amgen is an Equal Opportunity employer and will consider all
qualified applicants for employment without regard to race, color,
religion, sex, sexual orientation, gender identity, national
origin, protected veteran status, or disability status.