Senior Associate QA, Global Distribution Quality (GDQ)

  
 

Senior Associate QA, Global Distribution Quality (GDQ) 
  
 

What you will do 


We are seeking a highly motivated individual for our Global Distribution Quality (GDQ) team. This is an incredibly exciting opportunity to join a team of quality professionals in global distribution team. The Sr. Associate QA position will implement and oversee global product distribution and transportation from Amgen’s Global Supply Hubs to Amgen’s global markets, and provide QA oversight of QA activities for Global Supply Chain operations.

Working independently, the individual will be responsible for, but not limited to the following:

Perform QA Contact role on the Quality Events, Change Control records, Corrective and Preventive Actions, as well as QA triage of Distribution complaints.

Work closely with all relevant partners for the end-to-end process and ensure compliance to GMP/GDP.

Act as subject matter expert (SME) for transportation related Quality Processes

Collaborate with the 3rd Parties to ensure alignment to service levels, identifying and implementing performance improvement

Prepare, review and approve SOPs and other GMP/GDP documentation in compliance with corporate and regulatory requirements, to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations

Understand and incorporate risk management strategy into overall supply chain strategy

Provide support for logistic service provider and transportation service provider oversight

Support in tactical activities for internal/external audits and inspections as part of the audit/inspection team

Provide quality expertise and guidance to operational staff and within multi-functional Amgen teams

Take part in operational improvement initiatives, programs, and projects

Develop solutions that are thorough, practical, and consistent with functional objectives

Ownership of supplier metrics, performance assessments, and other key documents to inform the health of supplier relationships.

Work under minimal supervision in line with Amgen Values and Leadership Attributes

  
 

What we expect of you 
  
 Basic Qualifications and Experience 

We are all different, yet we all use our unique contributions to serve patients. The quality professional we seek is a strong leader with these qualifications:

Bachelor’s degree in science or engineering and 2+ years of professional experience in related fields.

Understanding of GMP/GDP requirements.

Familiarity with logistics processes of parcel, transport, and warehousing providers.

Experience in Validation/Qualification of processes, equipment, and facilities.

Deep technical writing skills.

Independent self-starter, able to work autonomously, under pressure and in teams.

GMP/GDP knowledge and understanding of pharmaceutical regulations.

Energetic, detail oriented, highly motivated with a “can do” outlook.

Change management skills.

Ability to communicate across all levels of the organization.

Effective written and verbal communication skills.

Experience with Microsoft Office Tools including Excel, Word, and PowerPoint.

Ability to multi-task and prioritize

  
 

What you can expect of us 
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

  
 

Apply now 


for a career that defies imagination

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

 

careers.amgen.com 


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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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, disability status, or any other basis protected by applicable law.

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.