Senior Associate Quality Assurance Specialist
2 days ago
We are seeking a Senior Associate Quality Assurance professional to join our team. This role is responsible for ensuring quality standards are met through collaboration with internal teams, external partners, and suppliers.
Key Responsibilities:- Partner QA Management: Ensure adherence to quality agreements with external partners, identifying performance improvement opportunities, and managing supplier relationships.
- Partnership Assessments: Perform partner assessments related to Change Control and Deviation records, ensuring alignment with quality standards.
- Quality Support: Provide various QA support tasks in accordance with quality agreements, including document revisions, redactions, and supporting partner audits.
- Process Compliance: Collaborate with all key stakeholders to ensure compliance with GMP/GDP regulations throughout the process.
- Documentation & SOPs: Prepare, review, and approve Standard Operating Procedures (SOPs) and other GMP/GDP documentation in compliance with corporate and regulatory requirements.
- Supplier Partnerships: Partner with external suppliers to ensure alignment with quality expectations and regulatory requirements.
- Risk Management: Incorporate risk management strategies into the overall external supply lifecycle to mitigate potential risks.
- Audit Support: Support tactical activities related to internal/external audits and inspections, ensuring compliance with regulatory standards.
- Operational Improvement: Participate in operational improvement initiatives, programs, and projects that drive efficiency and compliance.
- Performance Metrics: Own business metrics, conduct performance assessments, and manage key documents that reflect the health of external supplier and partner relationships.
This is an autonomous role that requires minimal supervision and aligns with Amgen's Values and Leadership Attributes to drive performance and compliance.
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