Specialist QA, Global Supply Quality

Career Category

Quality

Job Description

ABOUT AMGEN

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

 ABOUT THE ROLE

In this role you will be serving patients through internal collaboration with Amgen’s global quality teams, manufacturing sites and external engagement with suppliers of raw materials and devices.   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 Amgen’s Global Supply Quality team supporting oversight and maintenance of external suppliers and contract manufacturers.

Roles & Responsibilities:

• Periodic review and updates to quality agreements to ensure alignment to Amgen expectations and to address needs depending on material type.
• Documentation review and approval including: supplier manufacturing records, investigation reports, Amgen quality records, and validation records (process & analytical) .
• Evaluation and documentation of raw materials and devices for changes to incoming inspection profiles
• Oversight and completion of supplier assessments and documentation to support product complaints.
• Ownership of supplier metrics, performance assessments, and other key documents to inform the health of supplier relationships.
• Review and approval of change control records for supplier changes.
• Management of supplier audit records, ensuring on time completion and CAPA closeout activities are documented with appropriate closeout evidence.
• 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.
• Develop solutions that are thorough, practical, and consistent with functional objectives 
• This role may require working in shifts or extended hours within the same shift to support global time zones.

Basic Qualifications and Experience:

• Master’s degree with 10 years of experience in manufacturing and quality management systems or a related field OR
• Bachelor’s degree with 12 to 13 years of experience in quality management systems or a related field OR

Functional Skills:

Must-Have Skills:

• Minimum of 10 years working in a cGMP manufacturing environment with a strong understanding of regulatory requirements and expectations.

Good-to-Have Skills:

• Experience in creating digital solutions and working within computerized systems
• Experience in investigations, project management and trending and analysis  

• Relevant experience in Supplier Management, Intermediates, raw materials, packaging components and manufacturing.
• Understanding of the applicable manufacturing/testing processes and regulatory requirements (i.e. Intermediates, API manufacturing processes)
• Desire to partner with internal and external stakeholders 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 manage multiple priorities successfully.
• Team-oriented, with a focus on achieving team goals
• Strong presentation and public speaking skills.

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 with 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.

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