Specialist 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.

Specialist Quality Assurance

What you will do

Lets do this. Lets change the this vital role you will provide quality assurance support to the PQ organization as a subject matter expert of quality systems and this team-based role you will directly add to the success of the Product Quality team by collaborating within PQ and with diverse levels in functional areas including Supply Chain Manufacturing Quality Control Quality Assurance Regulatory Quality Engineering International Quality and Process development on projects issue resolution and investigations. The QA Specialist will use technical abilities and knowledge of QMS processes procedures and regulations to lead and deliver quality assurance responsibilities while owning reviewing and/or approving Product Quality records and documentation including: product specifications in-process control specifications specification technical reports annual product reviews (APRs) international expansion forms change control records appendix docs (data sheets and data analysis) Deviation Investigations/Root Cause Analysis CAPAs analytical comparability protocols analytical comparability reports and procedures. Additionally this role will approve commercial variation records (GDCR) and may provide training to other staff.

Responsibilities:

As a team member you will use your technical abilities to execute transactions in GMP systems (Veeva CDOCs Trackwise etc.) and may include additional business process support for APRs and site audits as needed. The QA specialist may also support managing products in the annual product review cycles at Amgen.

• Provide QA Systems expertise and QA support to the Product Quality organization (PQ and Stability) by working within a team environment.

• Provide Product Quality QA support to one or more of Amgens clinical and commercial products by working directly with Product Quality Leaders and Principal Product Quality Leaders on QA tasks.

• Responsible for QA tasks in support of both clinical and commercial Product Quality Leaders including ownership QA review and approval of documents (Protocols Reports Specifications IPCs Annual Product Review etc.) and execution of transactions (Owner and/or QA Contact) in relevant GMP systems (VEEVA CDOCS Change Control Deviation/CAPA etc.) and may include additional business process support.

• Support of audits/inspections APR management and other processes as required.

• Supporting/facilitating continuous improvement initiatives intended to increase Quality systems efficiencies within and outside of the PQ organization.

• Interact with other functional areas within Amgen such as Corporate Quality International Quality Quality Control Regulatory Process Development Site Quality Assurance Supply Chain Manufacturing etc.

What we expect of you

We are all different yet we all use our unique contributions to serve patients. The professional we seek will have these qualifications.

Basic Qualifications:

• Doctorate degree Or

• Masters degree and 2 years of Quality Operations Scientific or Manufacturing experience Or

• Bachelors degree and 4 years of Quality Operations Scientific or Manufacturing experience Or

• Associates degree and 8 years of Quality Operations Scientific or Manufacturing experience Or

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

Preferred Qualifications:

• Understanding of pharmaceutical sciences quality compliance and regulatory requirements associated with biologics and/or synthetics manufacturing and QC testing for clinical and/or commercial products.

• General understanding of biopharmaceutical bulk and drug product development and manufacturing and general knowledge of cGMPs.

• Previous experience using VEEVA Trackwise and other Amgen quality systems.

• Quality Assurance experience reviewing and approving cGMP documentation (Protocols Reports Specifications SOPs etc.).

• Strong Investigation skills (related to Deviations/CAPAs/EVs) and/or experience owning change control records.

• Experience with Amgen variation management processes and systems.

• Experience working on a cross-functional team in a matrix environment and strong project management skills.

• Excellent written and verbal communication skills including facilitation and presentation skills.

• Competency in interacting with Senior Management.

• Strong organizational skills and the ability to manage and prioritize multiple/competing tasks and deliverables.

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 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.

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 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 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.

Salary Range