Quality Control Associate - Days

Amgen

Posted 7 days ago

Full Time

West Greenwich, Rhode Island

In Person

Smart Summary

Responsibilities

The associate will perform and review analytical testing in a cGMP laboratory, including in-process, release, and stability samples. Responsibilities also include maintaining accurate laboratory documentation, operating sophisticated instrumentation, and supporting continual improvement initiatives.

Qualifications

You have a high school diploma with 2 years of quality experience, or an Associate's degree with 6 months of quality experience. Experience with HPLC/UPLC, general chemistry methodologies, and laboratory investigations is preferred.

Must Have Skills for ATS

HPLC/UPLC

capillary electrophoresis

Appearance

Color

Clarity

pH

Osmolality

Polysorbate

Protein Concentration

Sub-Visible Particle testing

cGMP

GDP

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 include the following:

  • 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 OR
  • Associate’s degree and 6 months of Quality experience OR
  • 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.


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.

Apply now and make a lasting impact with the Amgen team.


careers.amgen.com

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.

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Salary Range

62,571.90USD -84,656.10 USD

Amgen

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We helped establish the biotechnology industry, and we remain on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. Our investment in research and development has yielded a robust pipeline that builds on our existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases. Amgen is one of 30 companies comprising the Dow Jones Industrial Average®, and part of the Nasdaq-100 Index®. In 2024, Amgen was named one of the “World’s Most Innovative Companies” by Fast Company and one of “America’s Best Large Employers” by Forbes. For more information, visit Amgen.com and follow us on X, LinkedIn, Instagram, TikTok, YouTube and Threads. 🔗 Community Guidelines: https://wwwext.amgen.com/community-guidelines 🔗Global Privacy Statement Directory: www.amgen.com/dp Special Advisory: Please be cautious of scam recruitment offers claiming to be from Amgen. Such scams may come from various sources, including fake websites and/or unsolicited emails and seek to obtain personal data or payment from victims by offering jobs that do not exist. Please be advised that Amgen would never ask for payment to progress a job application. When in doubt, please check to see if the position in question is posted on this website before applying. Additionally, please report any suspicious recruiting activity to https://complaint.ic3.gov/ and thank you for your assistance.
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