Manager, Quality Assurance
Company: Amgen
Location: West Greenwich
Posted on: May 8, 2022
Job Description:
HOW MIGHT YOU DEFY IMAGINATION?Youve earned your degree. How
will you use that achievement to reach your goals? Do more with the
knowledge youve worked hard to acquire and the passion you already
have. 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. Become the professional you are meant to be in this
meaningful role.Manager, Quality AssuranceLiveWhat you will doLets
do this. Lets 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.Additional Responsibilities:
- 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
- Develop and communicate goals and objectives to staff and key
partners
- 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
leadership
- Partner with internal personnel at various management levels to
resolve issues, establish direction, obtain resources, and drive
change
- Review and approve operational procedures, product
manufacturing procedures, process validation protocols
- Authorize environmental characterization reports and change
control documents
- Approve non-conformances, representing QA on project teams and
approving change-over completion controls
- Lead investigations, as well as lead plant and site auditsThis
position will be responsible for shifts 2 and 3. Shift 2 is 1 pm -
11 pm, and shift 3 is 10 pm - 8 am. Hours worked will be determined
depending on need.WinWhat we expect of youWe are all different, yet
we all use our unique contributions to serve patients. The
dedicated professional we seek is a strong leader with these
qualifications.Basic Qualifications
- Doctorate degree OR
- Masters degree and 3 years of Quality experience OR
- Bachelors degree and 5 years of Quality experience OR
- Associates 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 resourcesPreferred Qualifications
- Bachelors 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
- Ability to build strong and collaborative partnerships with
client groups and influence changes in practices to ensure
compliant manufacturingThriveSome of the vast rewards of working
hereAs 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 Plancomprising health, finance and
wealth, work/life balance, and career benefitswith compensation and
benefits rated above 4 stars (out of 5) on GlassdoorApply nowfor a
career that defies imaginationObjects in your future are closer
than they appear. Join us.careers.amgen.com
Keywords: Amgen, Warwick , Manager, Quality Assurance, Executive , West Greenwich, Rhode Island
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