Quality Assurance Specialist Role
Job Description:
We are seeking a highly skilled Quality Assurance Specialist to play a key role in ensuring the quality and compliance of our manufacturing operations.
* Serve as the site QA point of contact, providing technical expertise, feedback, and guidance on QA and compliance matters.
* Manage assigned areas of the Quality Management System (QMS) to ensure product manufacturing aligns with GMP and regulatory standards.
* Oversee QMS elements including deviations, change control, CAPA, internal/external audits, customer complaints, vendor management, and the review and approval of manufacturing batch records and production materials.
* Generate, review, and approve SOPs and other documentation related to areas of responsibility.
Requirements:
Strong understanding of GMP compliance and quality standards.
* Excellent attention to detail with significant experience in document review.
* Proficient in technical writing, including deviation reports and SOPs.
* Strong time management and multitasking abilities.
* Demonstrated ability to drive task completion, resolve issues, and maintain high-quality standards.
Benefits:
Collaborative and dynamic work environment.
Opportunity to contribute to site-wide continuous improvement initiatives.