25 days old

Specialist QA

West Greenwich, RI 02817
  • Job Code

Job ID: R-107547
Location: West Greenwich, RI, US


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.

Quality Assurance Specialist


What you will do

Let's do this. Let's change the world. In this vital role you will have responsibility for On The Floor(primary role)and Off The Floor activities for Quality Assurance4thShift(SaturdaythroughMonday 7am -7pm). 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. Theprimaryfocus of this roll will be to support On The FloorwithOff The Flooractivitiesas required by the needs of the department.Amgen's Quality Assurance Shift4provides coaching, guidance and direction to Manufacturing, Quality Control, Supply Chain and Facilities & Engineering staff in regard to compliance and quality systems.

Responsibilities include the following:
  • Provide Quality oversight to ensure that operations products are manufactured, tested, stored, and distributed according to current Good Manufacturing.
  • Practice (cGMP), Good Distribution Practices (GDP) and other applicable regulations.
  • Ensure that facilities, equipment, materials, organization, processes, procedures and products comply with cGMP practices and other applicable regulations.
  • Perform review and approval of cGMP processes, procedures, documents and records, including but not limited to Nonconformance, Corrective Action/Preventative Actions (CAPA), Change Control records and validations, Raw Materials and Drug Substance documentation.
  • 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.
  • 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.
  • 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 professional we seek is a collaborative individual with these qualifications.

Basic Qualifications:

Doctorate degree


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


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


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


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
  • 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
  • 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 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 Power Point

Apply now

for a career that defies imagination

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


Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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, or disability status.



Posted: 2020-11-07 Expires: 2020-12-08

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Specialist QA

West Greenwich, RI 02817

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