Specialist Quality Control

Amgen•West Greenwich, RI

1d•Onsite

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. 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 Quality Control What you will do Let’s do this. Let’s change the world. In this vital role you will complete and review analytical testing in our cGMP laboratory. The role will be on-site based out of Amgen Rhode Island and will work under the mentorship of the front-line manager. The QC Bioanalytics team provides analytical expertise in testing the following: in-process, release and stability samples. The laboratory employs a variety of test methodologies that use sophisticated equipment including: HPLC/UPLC, capillary electrophoresis and general chemistry methodologies such as: Appearance, Color, Clarity, pH, Osmolality, Polysorbate, Protein Concentration, and Sub-Visible Particle testing.

Requirements

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

Nice To Haves

Experience leading teams, projects, or programs
Experience performing analytical testing per Methods
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
Demonstrated innovative thinking and ability to transform work organizations
Strong technical writing skills within a highly regulated environment
Exposure to Operational Excellence initiatives
Demonstrated ability to navigate through ambiguity and provide a structured problem solving
Demonstrated ability to coordinate multi-functional project teams and deliver on schedule
Analytical testing experience in the following technologies: HPLC/UPLC (Glycan, Peptide, SEC, CEX, HIC, and/or Titer), Capillary Electrophoresis (CE SDS, cIEF, and/or cOligo), and/or general chemistry testing including UV, Osmolality, pH, polysorbate, subvisible particles, appearance, color and clarity

Responsibilities

Follow safety guidelines, cGMPs (Good Manufacturing Practices) and other applicable regulatory requirements
Generate complete, accurate, and concise laboratory documentation using electronic systems and laboratory notebooks
Ensures that facilities, equipment, materials, organization, processes, procedures and products follow cGMP practices and other applicable regulations
Operate laboratory equipment and instrumentation
Performs review and approval of assays, documents and records
Supports Continual Improvement initiatives
Alerts management of quality, compliance, supply and safety risks
Participate in laboratory investigations
Perform general laboratory housekeeping activities
Completes required assigned training to permit carry through of required tasks
Performs additional duties as specified by management

Benefits

health and welfare plans for staff and eligible dependents
financial plans with opportunities to save towards retirement or other goals
work/life balance
career development opportunities
Retirement and Savings Plan with generous company contributions
group medical, dental and vision coverage
life and disability insurance
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