Associate Quality Control

Amgen Inc. (IR); West Greenwich (RI); On-site; USD 63,000 - 85,000; Full time

Job summary

Amgen Inc. in Rhode Island is seeking an Associate Quality Control professional to support QC Centralized Raw Material Testing in the Wet Chemistry Laboratory.

This is an administrative shift, Monday through Friday, based in Amgen Rhode Island, ensuring raw materials meet Amgen specifications for production. You will generate and review laboratory documentation, operate instruments, and participate in investigations.

Qualifications

• High school diploma / GED with 2 years quality or operations experience OR an Associate’s degree with 6 months of experience OR a Bachelor’s degree.
• Experience performing analytical testing per Methods and/or Compendia is preferred.
• Experience with QC analytical systems and quality systems is preferred.

Responsibilities

• Follow safety guidelines, cGMPs and other regulatory requirements.
• Generate complete, accurate laboratory documentation using electronic systems and notebooks.
• Ensure facilities, equipment, materials and processes comply with cGMP and regulations.
• Operate laboratory equipment and instrumentation.
• Review and approve assays, documents and records.
• Support continual improvement initiatives.
• Identify and communicate risks to management.
• Participate in laboratory investigations.
• Perform general laboratory housekeeping.
• Complete required training to perform tasks.

Skills

Interpersonal communication

Team collaboration

Project leadership

Technical writing

LEAN/Operational Excellence

Analytical testing

Quality systems

Education

High school / GED with 2 years quality/ops experience or Associate’s + 6 months or Bachelor's degree

Tools

QC analytical systems

Regulatory documentation tools

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. 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.

Associate Quality Control

What you will do

In this vital role you will provide support for QC Centralized Raw Material Testing in the Wet Chemistry Laboratory at Amgen Rhode Island. The role will be based out of Amgen Rhode Island and will work under the guidance of the hiring manager. It is an administrative shift, Monday through Friday. The Raw Material Centralized Testing team provides analytical expertise in testing raw materials to meet Amgen specifications and ensure a constant supply of raw materials for Amgen products. The laboratory employs a variety of test methodologies from basic wet chemistry identifications and titrations to complex instrumental analysis of a substance’s critical parameters. The team provides these crucial services for the entire Amgen production network, to ensure only the highest quality raw materials are used to create products for our patients.

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 execution of required tasks
• Performs additional duties as specified by management

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is a great teammate with these qualifications.

Basic Qualifications

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

Preferred Qualifications

• Experience performing 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
• 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. Refer to the Work Location Type in the job posting to see if this applies.

Salary Range 62,571.90USD -84,656.10 USD

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.

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