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Manager Quality Control

Employer
Amgen
Location
West Greenwich, RI
Start date
Jul 30, 2021

View more

Discipline
Quality, Quality Control
Required Education
High School or equivalent
Position Type
Full time
Hotbed
Pharm Country, Best Places to Work

Job Details

The Quality Control (QC) Manager position will supervise a team responsible for QC Equipment Management at Amgen Rhode Island and will contribute to fostering and further developing the culture of Safety, Quality, and Lean Leadership.

The QC Manager will contribute directly and provide oversight to a team responsible for the following functions in support of core QC laboratory operations:

  • End to end life cycle for QC equipment, including the procurement, development and execution of validation and change control strategy/ownership, oversight of general and preventive maintenance activities, and decommissioning as required.
  • Site SME/Representative on QC System Owner Network (fields requests/provides advice to other sites, alignment decisions with other sites)
  • Document ownership of Master List QC Equipment, QC and Manufacturing Computerized Analytical Lab Systems List
  • Quality review Data Integrity Assessments for computerized systems and Function Tests done by Automation (alarm changes, graphic changes, and parameters)
  • Comply with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety and Laboratory Controls

Basic Qualifications:

  • Doctorate degree
  • OR
  • Masters degree and 3 years of Quality or Equipment Management experience
  • OR
  • Bachelors degree and 5 years of Quality or Equipment Management experience
  • OR
  • Associates degree and 10 years of Quality or Equipment Management experience
  • OR
  • High school diploma / GED and 12 years of Quality or Equipment Management experience

Preferred Qualifications:

  • Experience managing staff and/or leading teams, projects, programs or directing the allocation of resources
  • Experience with equipment procurement, development and execution of validation, general and preventive maintenance activities
  • 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 productivity and enable LEAN principles across different functions
  • Experience with supporting staff training, career development and performance management
  • Establishment and tracking 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 with a demonstrated ability to influence different styles
  • Demonstrated 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

#OPERATION21


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.

Company

We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.

We live the mission.

We win together.

We thrive on continual challenge.

Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.

At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.

Connect with us to explore how you can Win, Live, and Thrive at Amgen.

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Company info
Website
Phone
805-447-1000
Location
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States

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