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 QA

Live

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

What you will do

The Quality Assurance Specialist will be responsible for On The Floor activities for Quality Assurance 2nd Shift (Tuesday through Friday 1pm – 11pm). 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 Specialist Quality Assurance Shift 2 provides coaching, guidance and direction to Manufacturing, Quality Control, Supply Chain and Facilities & Engineering staff in regards to 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 Distribution Practices (GDP) and other applicable regulations.
  Ensures that facilities, equipment, materials, organization, processes, procedures and products comply with cGMP practices and other applicable regulations.
  Performs review and approval of cGMP processes, procedures, documents and records, including but not limited to Deviations and 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 changes that could potentially impact product quality are assessed according to procedures.
  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 execution of required tasks.
  Drive operational improvement initiatives, programs and projects.

What we expect of you

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

Basic Qualifications

• Doctorate degree

  Or

  Master’s degree and 3 years of Quality, Manufacturing, Process Development or Process Engineering experience

  Or

  Bachelor’s degree and 5 years of Quality, Manufacturing, Process Development or Process Engineering experience

  Or

  Associate’s degree and 10 years of Quality, Manufacturing, Process Development or Process Engineering experience

  Or

  High school diploma / GED and 12 years of Quality, Manufacturing, 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

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Please note that you should be in your current position for at least 18 months before applying to internal positions. Staff must notify their current manager if invited for an interview. In addition, Staff are ineligible to apply for open positions if (a) their performance is currently being managed on a performance improvement plan (PIP) or other locally utilized formal coaching document or (b) their most recent performance rating was not a “Partially Meets Expectations” or higher. Please visit our Internal Transfer Guidelines for more detailed information

GCF Level

GCF Level 05

Career Category

Quality

Position Type

Full time