Senior Associate Quality Assurance

Lets do this. Lets change the world. In this vital role you will be serving patients through internal collaboration with Amgens global quality teams, manufacturing sites and external engagement with contract manufacturing organizations. You will make key contributions to ensure high quality and right first time materials are received at the Amgen, build a resilient supply network and conclude with a positive patient experience.

In this role you will be part of Amgens Global Supply Quality team supporting oversight and maintenance of contract manufacturers.

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

• Enter analytical into LIMS
• Create and update LIMS sample plans
• Generate Certificate of Analysis
• Compile batch release documentation
• Perform QA Approver role on the Quality Events
• Initiate Quality records for supplier related changes
• 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
• Take part in operational and quality improvement initiatives, programs, and projects.
• Communicate effectively with stakeholders, ensuring alignment on quality objectives and compliance needs.

This role may require working in shifts or extended hours within the same shift to support global timezones.

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:

• Masters degree and 1 to 3 years of professional experience in related fields OR
• Bachelors degree and 3 to 5 years of professional experience in related fields OR
• Diploma and 7 to 9 years of professional experience in related fields
• Understanding of GMP/GDP requirements.
• Familiarity with raw material compendial testing
• Experience overseeing quality of suppliers or external parties
• Strong technical writing skills

Preferred Qualifications:

• Experience and strong familiarity with digital tools and computerized systems.
• 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

• Excellent analytical and troubleshooting skills.
• Strong verbal and written communication skills
• Ability to work effectively with global, virtual teams