Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Specialist Quality Assurance

Live

What you will do

Let’s do this. Let’s change the world! In this vital role you will support the Amgen Manufacturing Limited - Drug Substance and Support areas non-standard shift operations. As Specialist QA you will bring forth out of the box thinking, an agile attitude with a subject matter expertise and understanding of Quality processes and controls.

Specific responsibilities include but are not limited to:

• Perform review, approval and tracking of cGMP processes, procedures, testing (methods) in manufacturing, documents, and records, including but not limited to Deviations and CAPAs.
• Responsible for providing Quality oversight to ensure that operations for clinical and licensed pharmaceutical products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Laboratory Practices (cGLP), and other applicable regulations
• Performs review, approval and tracking of cGMP and cGLP processes, procedures, testing (methods) in manufacturing, documents, Deviation’s, and CAPAs, including but not limited to Process Monitoring Assessment (PMAFs), and validations
• Actively engage in Continues Improvement initiatives, programs, and projects.
• Vigilant ensuring that changes that could potentially impact product quality are assessed according to procedures.
• Certify that deviations from established procedures are optimally investigated and documented.
• Teamwork and partnership cross functionally to ensure the Quality Management System processes are implemented.
• Strategic advisor to senior management of quality, compliance, supply, and safety risks.
• Supports internal/external audits and inspections as part of the audit/inspection management team as needed.
• Support non-standard shift and extended hours including weekends, as per business needs
• Completes required assigned training to permit implementation of required tasks
• Represent QA on New Product Introduction (NPI) team

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients! The Specialist QA professional we seek is an Individual Contributor with these qualifications.

Doctorate degree

OR

Master’s degree & 3 years of Quality and/or Manufacturing support GMP regulated environment experience

OR

Bachelor’s degree & 5 years of Quality and/or Manufacturing support GMP regulated environment experience

Or

Associate’s degree and 10 years of Quality and/or Manufacturing support GMP regulated environment experience

Or

High school diploma / GED and 12 years of Quality and/or Manufacturing support GMP regulated environment experience

Beyond that, additional preferred qualifications are:

• Educational background in Life Science and/or Engineering.
• Validated expertise in Quality Systems such as Deviations, CAPA, and Change Control.
• Experience in electronic systems such as: Trackwise, Maximo, ARMS, MES, LIMS, SAP, PI Historian and/or PCS.
• Experience in computer systems validation or computer systems quality assurance (medical device and/or consulting background technical proficiency).
• Robust knowledge and experience with processes involved in manufacturing and distribution, QA, QAL, and Process Development.
• Experience with Validation of GxP applications, Validation Master Plan, Installation Qualification (IQ), Risk Assessment/GxP assessment, Operational Qualification (OQ), Performance Qualification (PQ), Protocols, Test Scripts, and/or Completion/Summary Reports approvals as per the compliance requirements.
• Validated experience as Quality Contact for complex projects and in Commissioning and Qualifications.
• Strong organizational skills, including ability to follow assignments through to completion.
• Enhanced skills in leading, influencing and negotiating.
• Ability to interact with regulatory agencies.
• Proven word processing, presentation, database, and spreadsheet application skills.
• Strong communication (both written and oral), facilitation and presentation skills in English and Spanish.
• Skills working independently and to optimally interact with all levels throughout the organization.
• Advanced data trending & evaluation knowledge and ability to evaluate compliance issues.

Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

• Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
• A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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