Specialist Quality Complaints

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.

Specialist Quality Complaints

What you will do and what we expect of you

Lets do this. Lets change the this vital role you will:

Duties:Ensure product complaint records are processed according to FDA guidelines SOPs and other regulatory agencies guidelines; Evaluate subject matter expert assessments; Provide guidance and technical advice to conduct complex complaint investigations determine corrective actions and determine steps necessary to ensure the proper level of control for product in distribution; Ensure quality of complaint records and applies analytical abilities to evaluate complex situations using multiple sources of information; Execute against prioritized work plans to ensure timely investigation and closure of records in adherence with pre-determined process step metrics; Provide feedback and guidance to improve quality performance and prevent recurrence of issues; Develop solutions to technical problems of moderate complexity; Screen evaluate report and resolve record integrity issues; Raise potential Quality issues to Management and intensify issues that could impede the ability to close records according to action plans. Support department continuous improvement activities and projects in accordance with applicable regulations and business goals and objectives; Serve as a Subject Matter Expert for the team responsible for reviewing device investigation reports and ensuring proper investigation; Support producthypercareby compiling and reviewing data; Representing the electromechanical team and working with the AI pilot project for the complaints process optimization; Direct discussions to define the scope of the Root Cause Analysis and Supplier Corrective Actions ensuring a thorough and strategic approach to issue resolution. May telecommute.

Requirements:Masters degree (or foreign equivalent) in Industrial Engineering or related field & 2 years of experience in the job offered or in an engineering-related occupation. Position requires 2 years of experience in the following:

1. Manufacturing testing processes including API Drug Substance Drug Product Packaging and Device manufacturing processes;

2. Quality and manufacturing experience in biotech or pharmaceutical industry;

3. Quality Management Systems including SalesforceTrackwise or SAP;

4. Electronic Document Management Systems including Veeva Vault Quality Box and Share point;

5. Global regulations including FDA 21 CFR 820 International Organization for Standardization ISO 13485 FDA cGMP and Device cGMP Regulations to align with regulatory guidelines during processing product complaints;

6. Operating project management tools including Microsoft Office Smartsheet or Miro; and

7. Identifying and escalating QualityDefects andcommunicating with contract manufacturing organizations or suppliers.

Contact:Interested candidatesplease apply via for job#R-232603.

Job type:Full Time position. The annual salaryrangefor this position in the U.S. is$108953.00- $135219.00per year. Also this position offers stock retirement medical life and disability insurance and eligibility for an annual bonus or for sales roles otherincentive compensation. For more detailsvisit 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) 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 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.

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.

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.