Amgen

Manager Quality Control

Employer
Amgen
Location
West Greenwich, RI
Posted
Jun 30, 2021
Ref
R-122857
Discipline
Quality, Quality Control
Required Education
High School or equivalent
Position Type
Full time

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.