Associate Quality Control - Nights

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

Benefits offered by this job

Discretionary annual bonus

Stock-based incentives

Flexible work models

Job summary

Amgen Rhode Island is seeking an Associate Quality Control - Nights to provide testing support for the QC Night Shift Team C (Saturday - Tuesday, 9:45pm – 8:15am). The Associate QC will ensure execution of routine tests including titers, endotoxins, bioburden, TOC, conductivity, and microbiology in a regulated environment.

You will generate precise laboratory documentation, operate instruments, review assays, and support continuous improvement while adhering to cGMP requirements and safety

Qualifications

• High school diploma / GED with 2 years quality experience or Associate’s with 6 months, or Bachelor's degree.
• Experience with analytical/biological testing preferred.
• Strong written and verbal communication in a regulated environment.

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 review and approval of assays, documents and records.
• Supports troubleshooting and problem solving.
• Alerts management of quality, compliance, supply and safety risks.
• Supports TRAs and deviations, as applicable.
• Supports and drives Continuous Improvement initiatives.
• Completes required assigned training to permit execution of required tasks.
• Performs additional duties as specified by management.

Skills

Interpersonal skills

Written and verbal communication

Team matrix collaboration

Problem solving

Education

High school diploma / GED

Associate’s degree

Bachelor’s degree

Tools

QC analytical systems

Quality systems

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 - Nights

What you will do

Let’s do this. Let’s change the world. In this vital role you will provide testing support for the QC Night Shift “Team C” (Saturday - Tuesday from 9:45pm – 8:15am) at Amgen Rhode Island. The Associate QC will be responsible for execution of routine tasks and testing including but not limited to time sensitive samples from Manufacturing (Titer/ Endotoxin/ Bioburden/ TOC/ Conductivity), Centralized Raw Material testing (compendial testing & microbiology), Environmental Monitoring and Critical Utilities, Sample Receipt and Aliquot.

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 review and approval of assays, documents and records
• Supports troubleshooting and problem solving
• Alerts management of quality, compliance, supply and safety risks
• Supports TRAs and deviations, as applicable
• Supports and drives Continuous Improvement initiatives
• 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 detail orinted with these qualifications.

Basic Qualifications

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

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
• Identify, manage, and enable LEAN principles across different functions
• 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

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

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

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted.

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

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.

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.

Equal Opportunity Statement

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.

Salary Range

62,571.90USD -84,656.10 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