Senior Specialist QA - AML Critical Deviations

Juncos, PR, US
Oct 07, 2020
Required Education
Bachelors Degree
Position Type
Full time

Are you looking for a meaningful new opportunity to test and growth your investigations skills? We have an immediate need for a Sr Specialist QA to join AML's Critical Deviations Organization. This is an outstanding opportunity to seek a variety of challenges and responsibilities in support to our manufacturing facility at Amgen Manufacturing Limited in Juncos, Puerto Rico.


The team leads critical investigations for the site to ensure they follow a broad approach and robust Corrective and Preventive Actions are identified.

We strive to consistently be:

  • Amgen leaders who drive continuous improvement, agile decision making, and model a Quality culture by setting the standard in Root Cause Analysis (RCA) and deviation management ensuring the supply of quality products while maintaining our regulatory standing.
  • A flexible, balanced, knowledgeable, and engaged workforce that can quickly adjust to the business needs.
  • A coordinated team of Subject Matter Experts (SMEs) in RCA and deviation management that enables Amgen's growth and differentiation.
  • Coaches and mentors that help others to improve the quality of their investigations.

  • Approve process validation protocols and reports for manufacturing processes.
  • Represent Quality on incident triage team.
  • Lead investigations.
  • Approve Environmental Characterization reports.
  • Release of sanitary utility systems.
  • Approve planned incidents.
  • Represent Quality Assurance (QA) on New Product Introduction team.
  • Own site quality program procedures.
  • Designee for Quality Assurance manager on as needed basis.
  • Initiate and lead cross functional teams
  • Collaborate and coordinate with higher level outside resources.


Doctorate degree & 2 years of Quality and/or Manufacturing experience in a GMP regulated industry


Master's degree & 6 years of Quality and/or Manufacturing experience in a GMP regulated industry


Bachelor's degree & 8 years of Quality and/or Manufacturing experience in a GMP regulated industry


  • Education field in Life and/or Engineering
  • Validated expertise in Batch Record Review, Quality Oversight, and Quality Systems such as Non-Conformance, CAPA and Change Control
  • Project management skills
  • Strong investigations and organizational skills, including ability to follow assignments through to completion
  • Expertise in root cause analysis and ability to transfer that knowledge to other staff
  • Enhanced skills in leading, influencing, and negotiating.
  • Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QC, validation, and processes development
  • Validated ability to interact with regulatory agencies
  • Strong word processing, presentation, database and spreadsheet application skills
  • Strong communication, both written and oral, facilitation and presentation skills in Spanish and English.
  • Strong skill in working independently and to optimally interact with various levels
  • Advanced data trending and evaluation
  • Ability to evaluate compliance issues

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.

Amgen focuses on areas of high unmet medical need and uses its expertise to strive for solutions that improve health outcomes and dramatically 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.

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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.