Specialist-Manufacturing Investigations

Amgen • Holly Springs, NC • 1h ago

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. 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, 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.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

Specialist-Manufacturing Investigations

What you will do

Let's do this. Let's change the world. In this vital role, you will be a key member of the team that investigates major deviations in the Amgen North Carolina Biologics Drug Substance Manufacturing plant. You will communicate and interface between the GMP manufacturing teams and stakeholder groups including, Process Development, Facilities & Engineering, Automation, EHSS, and Quality. This position is responsible for ensuring deviation investigations are successfully conducted and documented while driving improvements in the investigation process.

Manage Major deviation investigations, including assembling investigation teams, leading root cause analysis, development of CAPAs, and compliant documentation of all findings.

Drive improvements to the investigation process.

Present investigations to regulatory inspectors, internal auditors, and management.

Clearly communicate investigation progress to impacted areas and leadership.

Coordinate and effectively lead cross-functional teams through complex investigations, and complete milestones on-schedule.

Present complex topics to large and small groups at various levels and quickly understand and clearly communicate complex issues.

Build effective relationships across functions.

Navigate through ambiguity and provide a structured problem-solving approach.

Apply inductive and deductive reasoning in the investigation process

Clear and concise technical writing

Use Operational Learning Team strategies to promote open collaboration with staff to maximize investigation findings.

Develop tracking tools to ensure on-time closure and proactive review of deviation investigations.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The collaborative investigator we seek has a biologics Drug Substance manufacturing and investigations background with strong cross-functional project management and communication skills as well as the below qualifications.

Basic Qualifications:

High school diploma / GED and 10 years of Quality Control experience OR

Associate's degree and 8 years of Quality Control experience OR

Bachelor's degree and 4 years of Quality Control experience OR

Master's degree and 2 years of Quality Control experience OR

Doctorate degree

Preferred Qualifications:

5+ years related work experience (manufacturing, process development, or quality assurance) in biotech or pharmaceutical industry with progressively increasing responsibility

Experience with compliance, problem-solving, simple and complex root cause analysis tools (5-whys, fishbone, Kepner Tregoe Problem Analysis®, Design of Experiment etc.) critical thinking, project management, and quality systems.

Degree in Science or Engineering

Experience leading complex investigations

Experience using Veeva QMS for Deviation investigations and CAPAs

Demonstrated project management ability

Experience presenting to inspectors during regulatory inspections and internal audits.

Excellent written and verbal communication skills

Ability to work in a team matrix environment and build relationships with partners

Strong interpersonal skills

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, we'll support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

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

careers.amgen.com

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.

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