28 days old

Manager Quality Control

Amgen
West Greenwich, RI 02817
  • Job Code
    123959830
Amgen

Job ID: R-104305
Location: West Greenwich, RI, US 02817

Under minimal direction, the Manager Quality Control will be responsible for Microbiology Team on Administrative Shift (Monday - Friday).

Responsibilities include leading and supervision of staff, maintenance of the weekly lab schedule and prioritization of daily work tasks. Providing Quality oversight to ensure that processes are followed in accordance to current Good Manufacturing Practices (cGMP).

The Manager will ensure that facilities, equipment, materials, organization, processes, procedures and products align with cGMP practices and other applicable regulations. Perform review, approval and tracking of cGMP processes, procedures, documents and records, including but not limited to nonconformance records and CAPAs.

Additional Responsibilities:

  • Supports Continual Improvement and LEAN initiatives, programs and projects.
  • Ensures that changes that could potentially impact product quality are assessed according to procedures.
  • Ensures that deviations from established procedures are investigated and documented per procedures.
  • Ensures that records are complete, accurate, and documented according to written procedures and cGMP requirements.
  • Collaborates cross functionally as needed to ensure the Quality Management System processes are executed in accordance with established procedures.
  • Alerts senior management of quality, compliance, supply and safety risks.
  • Supports internal/external audits and inspections as part of the audit/inspection management team.


Basic Qualifications:

  • Doctorate degree
  • OR
  • Master's degree and 3 years of Quality experience
  • OR
  • Bachelor's degree 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
  • Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources


Preferred Qualifications:

  • Experience managing staff and/or leading teams, projects, programs or directing the allocation of resources
  • Bachelor's Degree in Microbiology
  • Excellent interpersonal, written and verbal communication skills with all levels within the organization
  • Ability to work in a team matrix environment and build relationships with partners
  • Identify, manage, and champion innovative projects to advance efficiency and enable LEAN principles across different functions
  • Experience with supporting staff training, career development and performance management
  • Establishment and review of department goals, strategies and KPIs
  • Experience in auditing and defending processes, procedures and decisions during regulatory inspections
  • Experience with various laboratory equipment and computer systems
  • Strong leadership and negotiation skills.
  • Innovative thinking and ability to transform work organizations
  • Exposure to Operational Excellence initiatives
  • Demonstrated ability to coordinate multi-functional project teams and deliver on schedule


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.

Join Us

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 patients.

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.



PI123959830
Posted: 2020-09-23 Expires: 2020-10-24

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Manager Quality Control

Amgen
West Greenwich, RI 02817

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