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.
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 relevant role.
Role Description
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. This role may require working in shifts or extended hours within the same shift.
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, effectiveness verification and documentation, as well as QA triage of Distribution complaints.
- Work closely with all relevant collaborators for the end-to-end process and ensure compliance to GMP/GDP.
- Act as subject matter expert (SME) for transportation related Quality Processes
- 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
- Collaborate with the 3rd Parties to ensure adherence to service levels, identifying and implementing performance improvement
- 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 cross 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 We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.
Basic Qualifications:
- 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.
- Strong technical writing skills.
Preferred Qualifications:
- Strong continuous improvement attitude and lean practices experience.
- Understanding of end-to-end supply chain business processes.
- Experience in project management across multiple departments and geographies.
- Quick process understanding, insight and visualizing.
- Strong analytical and problem-solving 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.
