
Raw Material Quality Assurance Manager
3 days ago
The Quality Oversight Specialist position is responsible for the quality and compliance oversight of raw material suppliers.
This role is an integral member of a multi-functional raw materials team, including business operations, analytical science, process development, and supply chain.
- Perform quality assurance contact role on quality events, change control records, corrective actions, and documentation.
- Collaborate with stakeholders to ensure end-to-end process compliance with GMP/GDP regulations.
- Prepare, review, and approve SOPs and other GMP/GDP documents in compliance with corporate and regulatory requirements.
- Work with raw material suppliers to align with quality agreements and identify performance improvement opportunities.
- Incorporate risk management strategy into the raw material lifecycle.
- Support periodic monitoring oversight activities and internal/external audits.
Key Responsibilities:
Develop solutions that meet functional objectives. Ownership of supplier metrics, performance assessments, and key documents.
Requirements:
Bachelor's degree in science or engineering and 2+ years of professional experience. Understanding of GMP/GDP requirements and familiarity with raw material compendial testing.
PREFERRED QUALIFICATIONS:
Strong continuous improvement approach and lean practices experience. End-to-end supply chain business processes understanding and project management skills.
We Expect:
A strong leader with excellent technical writing skills. Ability to work independently under pressure and communicate across all levels of the organization.
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