Amgen

Specialist QA - AML Site Deviation Management Quality Process Owner & SME

Employer
Amgen
Location
Juncos, PR
Posted
Jan 16, 2022
Ref
R-134949
Required Education
Bachelors Degree
Position Type
Full time

Specialist Quality Assurance AML Deviations Management Quality Process Owner and SME

Live

What you will do

Lets do this. Lets change the world! In this vital role you will support the Amgen Manufacturing Limited - Drug Substance and Support areas non-standard shift operations. As Specialist QA you will bring forth out of the box thinking, an agile attitude with a subject matter expertise and innate understanding of Quality processes and controls. Specific responsibilities include but are not limited to:

  • Perform review, approval and tracking of cGMP processes, procedures, testing (methods) in manufacturing, documents, and records, including but not limited to Deviations and CAPAs.
  • Actively engage in Continues Improvement initiatives, programs, and projects. Being also the continuous improvement champion.
  • Vigilant ensuring that changes that could potentially impact product quality are assessed according to procedures.
  • Certify that deviations from established procedures are optimally investigated and documented.
  • Teamwork and partnership cross functionally to ensure the Quality Management System processes are executed in accordance with established procedures.
  • Strategic advisor to senior management of quality, compliance, supply, and safety risks.
  • Supports internal/external audits and inspections as part of the audit/inspection management team including acting as Quality unit representative as needed.
  • Accountable for assigned training adherence to execute the appropriate tasks.
  • Support non-standard shift and extended hours including weekends, as per business needs

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients! The Specialist QA professional we seek is an Individual Contributor Leader with these qualifications.

Doctorate degreeORMasters degree & 3 years of Quality and/or Manufacturing support GMP regulated environment experienceORBachelors degree & 5 years of Quality and/or Manufacturing support GMP regulated environment experienceBeyond that, additional preferred qualifications are:
  • Educational background in Life Science and/or Engineering.
  • Validated expertise in Quality Systems such as Deviations, CAPA, and Change Control.
  • Experience in electronic systems such as: Trackwise, Maximo, ARMS, MES, LIMS, SAP, PI Historian and/or PCS.
  • Experience in computer systems validation or computer systems quality assurance (medical device and/or consulting background technical proficiency).
  • Robust knowledge and experience with processes involved in manufacturing and distribution, QA, QAL, and Process Development.
  • Experience with Validation of GxP applications, Validation Master Plan, Installation Qualification (IQ), Risk Assessment/GxP assessment, Operational Qualification (OQ), Performance Qualification (PQ), Protocols, Test Scripts, and/or Completion/Summary Reports approvals as per the compliance requirements.
  • Validated experience as Quality Contact for complex projects and in Commissioning and Qualifications.
  • Strong organizational skills, including ability to follow assignments through to completion.
  • Enhanced skills in leading, influencing and negotiating.
  • Ability to interact with regulatory agencies.
  • Proven word processing, presentation, database, and spreadsheet application skills.
  • Strong communication (both written and oral), facilitation and presentation skills in English and Spanish.
  • Skills working independently and to effectively interact with all levels throughout the organization.
  • Advanced data trending & evaluation knowledge and ability to evaluate compliance issues.

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 Plancomprising health, finance and wealth, work/life balance, and career benefitswith 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

Equal Opportunity Statement

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 a 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 an 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.

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.

Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.