Quality Assurance Specialist- QA for QC and Disposition

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.

Quality Assurance Specialist- QA for QC and Disposition

What you will do

Lets do this! Lets change the world!

In this vital role the Quality Assurance Specialist will implement the systems and capabilities required for disposition and for quality oversight of Quality Control activities, and then execute those processes as operations commence.

This position requires analytical thinking skills to ensure compliance and quality with GMP regulations for all operations and associated processes.

• Provide Quality Oversight, assistance, and guidance of the QC Laboratories for issues such as non-conformance investigations, change control proposals, instrument qualifications, and lifecycle activities.

• Disposition product and raw materials while ensuring compliance with Quality policies and procedures, cGMPs, SOPs and Amgen standards.

• Provide quality expertise and guidance and work with cross-functional partners to achieve standard lead time targets for disposition of raw materials and product.

• Own and/or approve quality records including deviations/CAPAs and change controls assuring adherence to procedural requirements and confirming assessments and evaluations of different stakeholders are complete and accurate.

• Own and review controlled documents, including Standard Operating Procedures (SOPs), Work Instructions and FORMs.

• Interact with Supplier (Quality) Management teams and Suppliers for escalated cases of deviations or any other material supply related issues.

• Provide support during GMP Quality audits & inspections.

• Evaluate compliance issues, provide recommendations to Quality Leadership.

• Support Lean Transformation and Operational Excellence initiatives

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 driven individual with these qualifications.

Basic Qualifications:

• High school diploma / GED and 10 years of Quality Operations or Laboratory experience OR

• Associates degree and 8 years of Quality Operations or Laboratory experience OR

• Bachelors degree and 4 years of Quality Operations or Laboratory experience OR

• Masters degree and 2 years of Quality Operations or Laboratory experience OR

• Doctorate degree

Preferred Qualifications:

• Educational background in a science field

• Excellent written and verbal communication skills, ability to work in a team matrix environment and build relationships with partners

• Ability to complete tasks autonomously, problem solve and provide updates to senior management, and identifying potential issues

• Knowledge of operations business processes, materials management, laboratory specifications and methods

• Demonstrated ability in problem solving and experience in leading Root Cause Analysis / Deviation investigations

• Experience working with dynamic cross-functional teams and demonstrated abilities in decision making

• Strong organizational skills, including ability to follow assignments through to completion

• Proficiency with Document Control, Change Control, Exceptions Management, and Laboratory Management Systems

• Previous disposition experience supporting raw materials and/or product

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.

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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.