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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.

Sr. Associate Quality

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will be responsible for PQA On the Floor in support of Manufacturing activities. Amgen’s Quality Assurance On-the-Floor position Shift 1 schedule is 4 days a week Tuesday through Friday 10 hours per day 6am – 4pm.

This position provides the opportunity to work directly with Manufacturing staff during bulk drug substance operations to facilitate real-time decision-making regarding quality requirements and deviations. This is an outstanding opportunity to foster a positive relationship and learning environment between Manufacturing and Quality staff and provide coaching, guidance and direction to Manufacturing, Quality Control and Facilities & Engineering staff regarding compliance and quality systems..

Responsibilities include the following:

Responsible for providing Quality oversight to ensure that operations products are manufactured, tested, stored, and distributed according to current Good Manufacturing.

Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations.

Ensures that facilities, equipment, materials, organization, processes, procedures, and products align with cGMP practices and other applicable regulations.

Performs review and approval of cGMP processes, procedures, documents, and records, including but not limited to Standard Operating Procedures (SOP), Batch Records, Nonconformance, Corrective Action/Preventative Actions (CAPA),

Author/review/approve quality documents, such as: SOPs, user requirements, risk assessments, training materials, engineering documents, automation documents, environmental qualification protocols/reports, validation protocols/reports.

Establish and enable LEAN practices.

Oversee and provide guidance during on-the-floor analytical testing.

Ensures that deviations from established procedures are investigated and documented per procedures.

Ensures that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.

Alerts senior management of quality, compliance, supply and safety risks.

Completes required assigned training to permit delivery of required tasks.

Drive operational improvement initiatives, programs and projects.

Win

What we expect of you

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

Basic Qualifications

Master’s degree

Or

Bachelor’s degree and 2 years of Quality, Manufacturing, Validation, Process Development or Process Engineering experience

Or

Associate’s degree and 6 years of Quality, Manufacturing, Validation, Process Development or Process Engineering experience

Or

High school diploma / GED and 8 years of Quality, Manufacturing, Validation, Process Development or Process Engineering experience

Preferred Qualifications

Scientific degree in Life Sciences or Physical Sciences or Applied Engineering or Manufacturing Technologies

Previous QA oversight of manufacturing, analytical and engineering activities

Experience in investigations, change controls, and CAPAs processes system knowledge

Direct Validation experience with pharmaceutical or biopharmaceutical processes

Ability to evaluate compliance issues and interact with regulatory inspectors

Experience and training in EDMQ, Trackwise, Maximo, LIMS

Experience in managing multiple, competing priorities in a fast-paced environment

Experience leading and/or developing teams

Direct bulk drug substance and drug product experience

Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff.

Ability to solve sophisticated problems and make scientific risk-based decisions

Experience representing Amgen while interacting with representatives of regulatory agencies

Experience of trending analysis

Demonstrated proficiency using Excel, Word and Power Point

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and enhances its expertise to strive for solutions that improve health outcomes and spectacularly improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, so we 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 increase 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.

careers.amgen.com