Quality Control Associate - Days

BioSpace; West Greenwich (RI); On-site; USD 65,000 - 90,000; Full time

Job summary

Amgen Rhode Island is seeking a Quality Control Associate I - Bioanalytics to perform and review analytical testing in a cGMP data-driven lab. The role reports to the front-line manager and covers in-process, release, and stability samples using methods including HPLC/UPLC and capillary electrophoresis.

You will maintain documentation, ensure compliance, operate instruments, partake in investigations, and support continual improvement; a relevant degree or experience is required, with GMP/GDP

Qualifications

• High school diploma or GED with 2 years quality experience, or
• Associate degree with 6 months quality experience, or
• Bachelor’s Degree/Master’s Degree in a relevant science field.
• Experience with HPLC/UPLC and capillary electrophoresis is preferred.
• Experience in laboratory investigations, method validation, audits, and QC processes.
• Ability to interpret scientific data and communicate findings clearly.
• GMP/GDP experience is preferred.

Responsibilities

• Follow safety guidelines and cGMP regulations.
• Generate accurate laboratory documentation and notebooks.
• Ensure facilities 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 alert management to quality, compliance, supply and safety risks.
• Participate in laboratory investigations and training.

Skills

Detail orientation

Strong communication

Self-motivated

Organizational skills

GMP/GDP experience

Education

High school diploma / GED

Associate degree

Bachelor’s degree / Master’s degree

Tools

HPLC/UPLC

Capillary electrophoresis

Chemistry testing methods

Job description

Join Amgens Mission of Serving Patients

At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll 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

Lets do this. Lets 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
• Associates degree and 6 months of Quality experience OR
• Bachelors 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, well 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.

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.