Specialist QC

Amgen • West Greenwich, RI

1d

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Specialist QC What you will do Let’s do this. Let’s change the world. In this vital role you will provide leadership and support for QC Centralized Raw Material Testing in the Instrumentation Laboratory at Amgen Rhode Island. The Specialist QC will contribute directly and provide support to core laboratory operations, including: Routine Raw Material Testing Review/Approval of results in LIMS Interfacing with CTLs and entering results in LIMS Support for troubleshooting and problem solving Support for method validations Oversight of material onboarding Lab Point of Contact for Compendial Compliance Site SME for instrumentation methods, procedures, equipment, etc. Support with quality records (e.g. TRA ownership, Minor deviation initiation, and SME for Major deviations) Document ownership for Raw Material testing procedures Provide leadership by mentoring and coaching team Instructor for multiple methods/equipment Presents during audits and inspections

Requirements

• High school diploma / GED and 10 years of Quality or Operations experience OR Associate’s degree and 8 years of Quality or Operations experience OR Bachelor’s degree and 4 years of Quality or Operations experience OR Master’s degree and 2 years of Quality or Operations experience OR Doctorate degree

Nice To Haves

• Experience leading teams, projects, programs or directing the allocation of resources
• Experience executing analytical testing per Methods and/or Compendia
• Experience with QC analytical systems and/or Quality systems
• 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 in auditing and defending processes, procedures and decisions during regulatory inspections
• Strong leadership and negotiation skills with a demonstrated ability to influence different styles
• Strong quality mindset
• Demonstrated innovative thinking and ability to transform work organizations
• Strong technical writing skills within a highly regulated environment
• Demonstrated ability to navigate through ambiguity and provide a structured problem solving
• Demonstrated ability to coordinate multi-functional project teams and deliver on schedule

Responsibilities

• Routine Raw Material Testing
• Review/Approval of results in LIMS
• Interfacing with CTLs and entering results in LIMS
• Support for troubleshooting and problem solving
• Support for method validations
• Oversight of material onboarding
• Lab Point of Contact for Compendial Compliance
• Site SME for instrumentation methods, procedures, equipment, etc.
• Support with quality records (e.g. TRA ownership, Minor deviation initiation, and SME for Major deviations)
• Document ownership for Raw Material testing procedures
• Provide leadership by mentoring and coaching team
• Instructor for multiple methods/equipment
• Presents during audits and inspections

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed