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.

Live

What you will do

Let’s do this! Let’s change the world!

Job Description

The Senior Associate Quality Assurance will be responsible for Plant Quality Assurance (PQA) On the Floor in support of Manufacturing activities. 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 a unique opportunity to foster a strong partnership and learning environment between Manufacturing and Quality staff. Amgen’s Quality Assurance On-the-Floor position Shift 2 (4 days a week; Tuesday through Friday, 10 hours per day 1pm – 11pm) provides coaching, guidance and direction to Manufacturing, Quality Control and Facilities & Engineering staff in regard to compliance and quality systems.

Responsibilities:

• Provide Quality oversight to ensure that operations products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations.

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

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

• Adhere to and enable LEAN practices.

• Provide guidance during on-the-floor analytical testing.

• Ensure that changes that could potentially impact product quality are assessed according to procedures.

• Ensure that deviations from established procedures are investigated and documented per procedures.

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

• Alert senior management of quality, compliance, supply and safety risks.

• Complete required assigned training to permit execution of required tasks.

• Support 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 vital attribute professional we seek will have 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 managing teams

• Direct bulk drug substance and drug product experience

• Ability to solve complex 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 PowerPoint

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 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.

careers.amgen.com