11 часов назад
QA Specialist - Raw Materials (Biopharma)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
QA Specialist - Raw Materials (Biopharma): Providing quality assurance oversight for raw materials and consumables used in clinical and commercial biopharmaceutical manufacturing with an accent on cGMP compliance, material release, supplier quality, and quality documentation. Focus on reviewing quality impacts, supporting deviations, investigations, CAPAs, and change controls, and managing retained material inventories.
Location: USA - NC - Durham - National Way
Company
supports clinical and commercial biopharmaceutical manufacturing operations.
What you will do
- Provide quality oversight for sampling, review, release, qualification, and disposition of raw materials and consumables.
- Review specifications, procedures, change controls, vendor notifications, and quality impact assessments.
- Support deviations, investigations, CAPAs, change controls, root cause analysis, and continuous quality improvement.
- Coordinate with Manufacturing, Supply Chain, Procurement, Warehouse Operations, Quality Control, Planning, and external suppliers.
- Assess risks related to material shortages, supplier performance, inventory management, planning decisions, and expedited material requests.
- Maintain raw material retains, client cell bank inventories, and client drug substance retains, including tracking and reconciliation.
Requirements
- Experience supporting quality assurance activities in a cGMP-regulated biopharmaceutical manufacturing environment.
- Ability to review quality documentation and assess manufacturing and regulatory impact.
- Ability to support supplier qualification, supplier quality investigations, and supplier performance monitoring.
- Ability to manage material traceability, storage, inventory locations, and reconciliation within electronic systems.
- Ability to collaborate cross-functionally with internal teams and external suppliers.
Culture & Benefits
- Full-time employment.
- Commitment to workplace diversity and equal employment opportunity.
- Work involves clinical and commercial biopharmaceutical manufacturing operations.
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