Senior Associate Quality Assurance

1 week ago

Holly Springs, United States Amgen Full time

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. 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.

Sr Associate QA - Quality Systems

What you will do

Let’s do this Let’s change the world

The Quality Management System (QMS) is the foundation that enables us to deliver on our mission to serve patients. In this role you will serve as Sr. Associate I in Quality Assurance responsible for specific systems within the QMS at ANC. This position provides the opportunity to work directly with cross functional stakeholders, the Amgen global network, and the site to implement, maintain, and improve critical systems.

  • Drive implementation of Quality Systems in compliance to Amgen Standards and Regulatory expectations

  • Track implementation progress and monitor systems performance and report status forums

  • Alert management of quality, compliance, and safety risks

  • Author/review/approve quality documents, such as SOPs, reports, and training materials.

  • Support Lean Transformation and Operational Excellence initiatives

  • Perform training impact assessments for controlled documents

  • Serve as site SME for Document Management and Learning and Performance, liaising with the global network for alignment and best-practice sharing and ensuring effectiveness, efficiency, and compliance at site

  • Participate in inspection preparation activities

  • Provides quality oversight for quality records including deviations/CAPAs, assuring adherence to procedural requirements and confirming assessments and evaluations of stakeholders are complete and accurate

  • Maintain and support the training program

  • Support continuous improvement initiatives by identifying training-related solutions to reduce deviations and enhance compliance

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 flexible, and driven individual with these qualifications.

Basic Qualifications:

  • High school/GED + 4 years Quality Operations or Laboratory work experience OR

  • Associate’s + 2 years Quality Operations or Laboratory work experience OR

  • Bachelor’s + 6 months Quality Operations or Laboratory work experience

  • Master's

Preferred Qualifications:

  • Educational background in a science field

  • Strong cGMP and GDP behaviors

  • Experience in biotechnology or pharmaceutical plant start up

  • Experience with Quality Management Systems, including Documentation Management and/or Learning and Performance

  • Knowledge of regulations, standards and guidelines associated with Quality Management Systems

  • Experience in monitoring performance and driving improvement

  • Demonstrated ability in problem solving

  • Capability to build strong and collaborative partnerships with stakeholders and partners and influence changes to ensure compliant, efficient, and effective operations

  • Experience working with dynamic cross-functional teams

  • Experience supporting audits and inspections

  • Strong organizational skills and ability to manage multiple tasks at one time, ability to follow assignments through to completion and meet timelines

  • Strong communication skills, both written and oral

  • Demonstrated ability to work as a team player and independently

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, 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

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.

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.

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