Senior Associate Quality Assurance

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its 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. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. 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.

What you will do

Lets do this! Lets change the world!

In this vital role you will be a part of our Amgen North Carolina Quality Assurance team. The role will support the inspection, sampling, and perform Raman Spectroscopy testing of raw materials that are received at the Amgen North Carolina site. This role will ensure that raw materials received for use in our cGMP manufacturing plants meet all specification requirements and master inspections characteristics required for use in our manufacturing process.

This role will also demonstrate leadership skills in support of scheduling, coordination, and staff training. There will be opportunities to advance Quality learning through additional responsibilities and training.

Inspect materials including biobags, tubing, filters, and other components to ensure all inspection-related specification requirements and master inspections characteristics are met

Perform sampling from containers of medias and other chemicals to facilitate the testing of samples

Use RAMAN technology with TruScan equipment to identify chemicals

Ensure that inspection & sampling results are complete and detailed according to written procedures and cGMP requirements

Responsible for accurately documenting inspection, sample, and test results in Amgens systems

Responsible for ensuring that characteristics that could potentially impact product quality are assessed according to procedures

Ability to determine the color and appearance of components match required attributes

Leads / Participates in inspections / walkthroughs to ensure that facilities, equipment, materials, organization, processes, procedures and products comply with cGMP regulations and other safety standards.

Oversee the warehouse's quality assurance, which encompasses managing quality documentation such as deviations / CAPAs, change controls, and work orders, ensuring compliance with procedural standards, and verifying that evaluations and assessments of various partners are thorough and precise.

Support inspection readiness activities including site audits and inspections

Maintains project plan commitments supporting critical projects

Leads and Supports Continual Improvement initiatives, programs and projects

Serve as a shift lead in the raw material inspection and sampling areas

Assist area management with the prioritization and scheduling of tasks

Serve as a trainer and subject matter expert in tasks associated with raw material inspections, samples, and testing

Author, own, review and approve controlled documents for the area including SOPs and FORMs

Initiate, and own deviation records and CAPAs associated with events and projects in ANCs raw material inspections, samples and testing areas

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a team player with these qualifications.

Basic Qualifications :

High school / GED 4 years Quality, manufacturing and / or other regulated environment experience OR

Associates 2 years Quality, manufacturing and / or other regulated environment experience OR

Bachelors 6 months Quality, manufacturing and / or other regulated environment experience OR

Master's

Preferred Qualifications :

Strong understanding of cGMP regulations and GDP requirements

SAP, LIMs, and TrackWise experience

Experience with RAMAN technology

Experience as a Trainer in raw material inspections, sampling, and testing

Ability to lift and perform physical activities with raw materials

Strong written and verbal communication skills

What you can expect from 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, including remote and hybrid work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

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 an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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.