Specialist Quality Assurance

Job Description

You will make key contributions to ensure high-quality and right-first-time materials are received at 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 with Amgen expectations and to address needs depending on material type.
- Documentation review and approval, including supplier records, investigation reports, Amgen quality records, and validation records.
- 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.

What we expect of you

Basic Qualifications:

- Doctorate degree OR
- Master's degree with 4+ years of experience in quality management systems or a related field OR
- Bachelor's degree with 6+ years of experience in quality management systems or a related field OR
- Diploma with 8+ years of experience in quality management systems or a related field.

Preferred Qualifications:

Must-Have Skills:

- Minimum of 2 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, raw materials, packaging components, and/or device manufacturing.
- Understanding of the applicable manufacturing/testing processes and regulatory requirements (i.e., API, Drug Substance, Drug Product, Packaging, Device manufacturing processes, and combination products).
- 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.

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