Specialist 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.

• Perform tactical batch disposition activities in support of lot release
• Enter and approve analytical data in LIMS
• Manage and drive Quality records to closure including deviation records, investigation reports
• Initiate Quality records for supplier related changes.
• Collaborate with Complaints team to request assessments, reviews complaint report and have comments addressed
• Provide data to the networks to support Quality Management 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.
• Take part in operational and quality improvement initiatives, programs, and projects.
• Communicate optimally with key collaborators, ensuring alignment on quality objectives and compliance needs.

We are all different, yet we all use our outstanding contributions to serve patients.

Basic Qualifications:

• Doctorate degree OR
• Masters degree and 4 to 6 years of quality assurance experience OR
• Bachelors degree and 6 to 8 years of quality assurance experience OR
• Diploma and 10 to 12 years of quality assurance experience

Preferred Qualifications:

Must-Have Skills:

• Working foundation in quality assurance roles.
• Minimum of 4 years working in a cGMP manufacturing environment with a strong understanding of regulatory requirements and expectations.
• Ability to have a positive impact on others; the ability to affect the behaviors of others by connecting with and encouraging them

Good-to-Have Skills:

• Experience in investigations, project management and trending and analysis
• Relevant experience in Supplier Management, raw materials, packaging components, and/or device manufacturing.
• Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes).
• Proven experience in designing and/or improving processes at conceptual level
• Desire to partner with internal and external key collaborators across teams
• Understanding of industry requirements/expectations of a robust Quality Management System and documentation.

Soft Skills:

• Excellent analytical and troubleshooting skills.
• Strong verbal and written communication skills
• Ability to work effectively with global, virtual teams
• High degree of initiative and self-motivation.
• Ability to prioritize successfully.
• Team-oriented, with a focus on achieving team goals
• Strong presentation and public speaking skills.