Quality Control Associate - Days

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

Benefits offered by this job

Retirement plan

Medical/Dental/Vision insurance

Stock-based long-term incentives

Flexible time-off plans

Flexible work models

Job summary

Amgen Rhode Island is seeking a Quality Control Associate I in Bioanalytics to perform analytical testing in a cGMP laboratory under mentorship. The role supports in-process, release and stability testing using instruments such as HPLC/UPLC and capillary electrophoresis.

The position requires adherence to safety guidelines, accurate documentation, and regulatory compliance, with on-site work and a strong benefits package.

Qualifications

• High school diploma / GED plus 2 years of quality experience.
• Associate’s degree plus 6 months of quality experience.
• Bachelor’s degree or Master’s Degree in a relevant field.

Responsibilities

• Follow safety guidelines, cGMPs and other applicable regulatory requirements.
• Generate complete, accurate, and concise laboratory documentation.
• 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.

Skills

Detail oriented

Organizational skills

Documentation

Communication skills

Education

High school diploma / GED

Associate’s degree

Bachelor’s degree

Master’s degree

Tools

HPLC/UPLC

Capillary electrophoresis

Analytical chemistry

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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. 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.

Quality Control Associate I - Bioanalytics

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 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.

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

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 oriented 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 degreeMaster's Degree

Preferred Qualifications

• 1-2 years’ experience in HPLC/UPLC, capillary electrophoresis and general chemistry methodologies such as: Appearance, Color, Clarity, pH, Osmolality, Polysorbate, Protein Concentration, and Sub-Visible Particle testing
• Demonstrated experience in laboratory investigations, method validation, audits, QC processes
• Proven ability to interpret scientific data
• Self-motivated, strong organizational skills and ability to manage multiple tasks at one time with minimal direction
• Strong communication skills (both written and oral), facilitation and presentation skills
• GMP/GDP experience

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. 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.

• 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.

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 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. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law. We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. 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