Senior Associate Quality Control

1005 Immunex Rhode Island Corporation; West Greenwich (RI); On-site; USD 79,000 - 107,000; Full time

Job summary

Amgen Rhode Island is seeking a Senior Associate Quality Control to support QC Centralized Raw Material Testing in the Wet Chemistry Laboratory, Monday–Friday 8:00 am–4:30 pm. The role provides technical SME oversight and ensures compliance with cGMP, safety, and quality systems.

The position requires a Master’s degree (or combinations listed) and hands-on experience in quality, manufacturing, or operations, with strong documentation and problem-solving skills to drive continuous improvement

Qualifications

• Master’s degree in a relevant field or equivalent combination of education and experience.
• Bachelor’s degree with 6 months quality/manufacturing/operations experience.
• Associate’s degree with 2 years quality/manufacturing/operations experience.
• High school diploma + 4 years in quality/manufacturing/operations.

Responsibilities

• Ensures facilities, equipment, materials, organization, processes, procedures and products comply with safety guidelines, cGMP practices and other applicable regulations.
• Generates complete, accurate, and concise laboratory documentation using electronic systems and laboratory notebooks.
• Operates laboratory equipment and instrumentation.
• Performs routine raw material testing.
• Management of the Raw Material Testing Master Schedule.
• Performs review and approval of assays, documents and records.
• Review/Approval of results in LIMS.
• Interfaces with CTL and enter results in LIMS.
• Site SME for specialized testing (Auto-titration, Colorimeter, FTIR, and SOR).
• Supports troubleshooting and problem solving.
• Alerts management of quality, compliance, supply and safety risks.
• Supports TRAs and deviations, as a technical SME.
• Support and drive Continuous Improvement initiatives.
• Instructor on several specialty tests.
• Document ownership for Raw Material testing procedures.
• Completes required assigned training to permit execution of required tasks.
• Performs additional duties as specified by management.

Education

Master’s degree

Bachelor’s degree and 6 months of Quality, Manufacturing, or Operations experience

Associate’s degree and 2 years of Quality, Manufacturing, or Operations experience

High school diploma / GED and 4 years of Quality, Manufacturing, or Operations experience

Job description

Career Category Operations Job Description

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.

Senior Associate Quality Control

What you will do

Let’s do this. Let’s change the world.

In this vital role you will provide support for QC Centralized Raw Material Testing in the Wet Chemistry Laboratory at Amgen Rhode Island. The Sr. Associate Quality Control (QC) position will provide support for QC Centralized Raw Material Testing in the Wet Chemistry Laboratory (Monday - Friday 8:00 am - 4:30 pm) at Amgen Rhode Island.

Responsibilities

• Ensures that facilities, equipment, materials, organization, processes, procedures and products comply with safety guidelines, cGMP (Good Manufacturing Practices) practices and other applicable regulations
• Generates complete, accurate, and concise laboratory documentation using electronic systems and laboratory notebooks
• Operates laboratory equipment and instrumentation
• Performs routine raw material testing
• Management of the Raw Material Testing Master Schedule
• Performs review and approval of assays, documents and records
• Review/Approval of results in LIMS
• Interfaces with CTL and enter results in LIMS
• Site SME for specialized testing (i.e. Auto-titration, Colorimeter, FTIR, and SOR)
• Supports troubleshooting and problem solving
• Alerts management of quality, compliance, supply and safety risks
• Supports TRAs and deviations, as a technical SME
• Support and drive Continuous Improvement initiatives
• Instructor on several specialty tests
• Document ownership for Raw Material testing procedures
• Completes required assigned training to permit execution of required tasks
• Performs additional duties as specified by management

Basic Qualifications

• Master’s degree
• Bachelor’s degree and 6 months of Quality, Manufacturing, or Operations experience
• Associate’s degree and 2 years of Quality, Manufacturing, or Operations experience
• High school diploma / GED and 4 years of Quality, Manufacturing, or Operations experience

Preferred Qualifications

• Experience executing analytical /biological 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
• Experience leading teams or projects
• 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
• 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 deliver on schedule

What you can expect of us

From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• 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.

Sponsorship

Sponsorship for this role is not guaranteed. 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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. 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, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Salary Range

Salary Range 78,724.45USD -106,509.55 USD

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 biologics manufacturing 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. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen