Skip to content
CV Rocket
Get started
How it worksThe enginePricingBlogContactSign in

Open nowPosted yesterday

Specialist Manufacturing

Amgen1,952 open roles

Pay
$107,545 – $145,503 a year
Where
US California Thousand Oaks
Work mode
Hybrid
Get the CV for this job

From $25 per CV, paid once. No subscription.

Your applicationOpen nowSpecialist ManufacturingAmgen · US California Thousand Oaks

  1. YouYes, apply to this one.

  2. CV RocketCV written for this posting.

  3. 25 readersRecruiter, hiring manager, skeptic. Round after round.

  4. CV RocketApplied on Amgen's own form.

The reply lands in your private mailbox

3×more interviews than doing it yourself with ChatGPT.

The clock on this job

Early applications get read.

13.7% of postings close within 7 days. Measured by our own scanner across the market. Amgen postings stay open a median of 36 days.

Share of postings closed within
  1. 2.3%1 day
  2. 4.8%3 days
  3. 13.7%7 days
  4. 22.1%14 days
  5. 37.6%30 days
  6. 59.1%60 days
This job: posted yesterday

Amgen median: 36 days open

The posting

Career Category

Manufacturing

Job Description

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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. 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.

Specialist Manufacturing

What you will do

Let’s do this. Let’s change the world. The External Supply (ES) Raw Material and Devices Quality Records (RMD QRO) global team plays a vital role in supporting the Amgen manufacturing network. Our work includes managing supplier notifications and investigations related to raw material and device defects, onboarding new or alternate raw materials, suppliers, sites, and managing life-cycle changes to existing materials or suppliers. The External Supply Specialist Manufacturing is expected to own and execute independently all the processes related to Raw Material and Devices (RMD) quality records, including Supplier Event Notifications and Investigations (EN/SICAR), Change Controls, Deviations (minor and major), Corrective and Preventive Actions (CAPAs), CAPA-Effectiveness Verifications. This Specialist Manufacturing will act as the External Supply QRO representative across functional teams and external suppliers to drive closure of quality records in a timely manner. The Specialist Manufacturing External Supply owns and manages quality records originating from manufacturing sites across the global Amgen network.

Responsibilities:

Responsibilities include, but are not limited to the following:

  • Own, manage, and close quality records (Supplier Event Notifications and Investigations (EN/SICAR), Change Controls, Deviations, Corrective and Preventive Actions (CAPAs), and CAPA-Effectiveness Verifications) under the company's quality management system procedures and ensure compliance with regulatory agency requirements.
  • Facilitation of cross-functional teams (internal and external to the site) with the goal of achieving robust and detailed investigation performance or timely implementation of supplier/raw material related changes.
  • Partner cross-functionally across the network to ensure maturity and execution of robust quality record process.
  • Lead investigation teams to identify meaningful root causes and robust corrective and preventative actions by effectively utilizing advanced root cause analysis tools (Causal Factor Analysis, Fault Tree Analysis, Kepner-Tregoe, etc.)
  • Manages closure of multiple quality records simultaneously and in a timely matter (Deviations, Change Controls, ENs, SICARs, CAPA, CAPA-EV).
  • Collaborate closely with External Supply Quality, ES SRE teams, Amgen sites, and suppliers to ensure robust supplier/raw material investigations, timely change implementation, and compliance with KPI metrics.
  • Build and present quality record summaries for Senior Management review. Provide timely and comprehensive process and status updates to senior management in multiple forums and keeping tracking tools updated.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The manufacturing professional we seek is diligent with these qualifications.

Basic Qualifications:

  • Doctorate degree OR
  • Master’s degree and 2 years of Quality and/or Manufacturing experience in the pharmaceutical, biotech or medical device industries OR
  • Bachelor’s degree and 4 years of Quality and/or Manufacturing experience in the pharmaceutical, biotech or medical device industries OR
  • Associate’s degree and 8 years of Quality and/or Manufacturing experience in the pharmaceutical, biotech or medical device industries OR
  • High school diploma / GED and 10 years of Quality and/or Manufacturing experience in the pharmaceutical, biotech or medical device industries

Preferred Qualifications:

  • 3+ years related work experience (manufacturing, process development, or quality assurance) in Biotech or pharmaceutical industry with progressively increasing responsibility and demonstrated experience in compliance, problem solving, critical thinking, project management, and quality systems.
  • Experience managing quality records (EN/SICAR, Change Controls, Deviations, CAPAs, CAPA-EV) using TrackWise or Veeva System
  • Project Management skills and experience. Demonstrated ability to coordinate and effectively participate in cross-functional project teams and deliver on schedule.
  • Experience in leading multiple, contending priorities in a fast-paced environment with minimal direction.
  • Excellent communication skills, both written and verbal (including technical writing and presentation skills) with ability to collaborate productively with technical and senior management staff.
  • Demonstrated ability to work autonomously, present data in an organized and logical manner, meet deadlines, prioritize work and communicate effectively.
  • Experience presenting to and interacting with representatives of regulatory agencies.
  • Demonstrated ability to navigate through ambiguity and provide a structured problem-solving approach.
  • Demonstrated ability to lead continuous improvement opportunities and complex cross-functional initiatives that enhance processes, improve operational efficiency, and support timely, compliant execution across internal teams and Amgen sites.
  • Proficient with Microsoft Office Tools (Word; Excel; PowerPoint; Project, Teams, Outlook)
  • Experience navigating and executing transactions in SAP (ERP) or S4HANA system.
  • Experience applying AI-enabled tools in a regulated environment.
  • Experience contributing to the design, development, or implementation of AI-enabled tools as part of process improvement initiatives or projects. Ability to translate business or quality process needs into practical solutions and evaluate outputs for accuracy, data integrity, and compliance with applicable requirements
  • Interpersonal and facilitation skills necessary to forge consensus among challenging client interests while ensuring objectives are met.
  • Ability to tactfully negotiate and positively influence peers and executive leadership.
  • Demonstrated ability to deliver results through living the Amgen values.
  • Strong negotiation skills when working with external suppliers and internal team members.
  • Ability to maintain remote working relationships with colleagues at other Amgen sites.

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, 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 where possible. Refer to the Work Location Type in the job posting to see if this applies.

Apply now and make a lasting impact with the Amgen team.

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.

Application deadline

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

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 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. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.

We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.

.

Salary Range

107,545.40USD -145,502.60 USD

From $25, paid onceGet the CV for this job

What happens when you press

One press. We do the rest.

  1. A CV for this posting

    Written against Amgen's own wording, from every piece of relevant proof in your profile.

  2. 25 readers review it

    Recruiter, hiring manager, skeptic and more read every draft, round after round. You get the best round.

    The review screen in CV Rocket: how each CV was read, round by round.

  3. We apply on Amgen's form

    Our application engine gets through the hardest forms there are. Where a question needs you, AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

    An application in CV Rocket: every answer filled in on the employer's form.

  4. Every reply, sorted

    Amgen's answer lands in your private mailbox, and we classify it on arrival: interview, question, rejection.

    The CV Rocket inbox: each employer reply classified as an interview, an action or a rejection.

  5. Reply with AI

    AI helps you write the email, checks it and sends it. We show you whether the recruiter read it.

  6. The interview in your calendar

    Full integration with your calendar. The invitation goes straight in.

    An interview invitation in the CV Rocket inbox, added to the candidate's calendar.
Get the CV for this job

From $25 per CV, paid once. No subscription.

Why it works

3×

more interviews than doing it yourself with ChatGPT.

ChatGPT writes a CV and never learns what happened to it. We see every reply. For each CV we know:

  • How it was written, and how the review scored it
  • When we applied, and how long after the posting went up
  • Which posting, which company, which city
  • Who got the interview, and who heard nothing

That is how we know which CVs get called.

Get the CV for this job

From $25 per CV, paid once. No subscription.

The numbers game

More applications. More interviews.

Every application goes out with its own CV, written for that posting and paid once. Send enough of them and the law of large numbers finds you the job.

Get the CV for this job
By hand5–10
With CV Rocket100
applications a day

Nearby

Live postings like this one

Same employer first, then the same role elsewhere.

Before you press

Straight answers

Get the CV for this job

From $25 per CV, paid once. No subscription.

What if my background isn't good enough?

We make the most of the background you have. The CV uses every piece of relevant proof your profile holds, and one of the 25 readers reads your whole profile and flags what the CV left out.

Do you really apply for me?

Yes, on the employer's own form, the hardest ones included. Where a question needs you, you answer it right there and AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

Is it a subscription?

No. You pay once per CV, from $25. Every application goes out with its own CV, written for that posting.

One job. One CV.
Paid once.

Pick the posting you want. We write for it, apply for you and catch the reply.

Get the CV for this job

From $25 per CV, paid once. No subscription.