QA Specialist

Career Category

Job Description

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.

QA Specialist

What you will do

Lets do this! Lets change the world!

In this vital role the specialist will leverage industry technical and quality systems knowledge to perform a comprehensive review of product manufacturing elements and execute a quality-critical disposition decision ensuring that batches are appropriately controlled.

The disposition specialist will lead and coordinate timely release of raw material product batches from assigned plants to ensure uninterrupted patient supply. The staff member will regularly present disposition status and metrics in a cross-functional leadership setting and proactively escalate supply interrupters. The individual will support waste reduction and patient supply at the site through leadership of and/or participation in continuous improvement initiatives.

• Partner with our colleagues in Manufacturing Supply Chain Facilities and Engineering and Automation to maintain our strong culture of Quality and Safety and ensure we continue to meet Amgen standards.

• Execute the Raw Material and Product disposition process as required per standard operating procedure.

• Compilation and presentation of disposition metrics and status

• Provide change control record quality assessments ensuring adherence to procedural requirements and regulatory expectations.

• Support of internal audits

• Direct interaction with regulatory agencies during on-site inspections

• Provides quality expertise and guidance to operational staff and within cross functional

Amgen teams

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

• Review and approves controlled documents

• Attain ERP/SAP system proficiency

• Expiration extensions

• Country Cluster Modifications

• Annual Product Review data verification/quality approval

• Import Documentation Requests

• Product / Material Transfers

• Ensure that operations align with applicable regulations and Amgen requirements relating to Good Manufacturing Practices Good Documentation Practices Safety and Controls Contribute to and drive continuous improvement projects in cross-functional collaboration.

• Represent the Quality function and provide quality oversight during the implementation of projects required to improve and deliver our departmental and manufacturing plant goals.

• Contribute to and drive digital innovation solutions and applications in cross-functional collaboration.

What we expect of you

We are all different yet we all use our unique contributions to serve patients. The Quality professional we seek is a dynamic flexible and driven individual with these qualifications.

Basic Qualifications:

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

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

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

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

• Doctorate degree

Preferred Qualifications:

• Educational background in a science field

• Experience with Quality Management Systems

• 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 manufacturing processes and/or materials management

• Demonstrated ability in problem solving

• 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 Controls Exceptions Management

• Previous disposition experience supporting raw materials and/or product

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) 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 and make a lasting impact with the Amgen team.

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. 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.

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