Quality Assurance Specialist II/III

Seran is seeking a Quality Assurance Specialist to support the daily activities of Serán’s Quality Assurance department supporting GMP clinical manufacturing operations. This individual will be responsible for reviewing and approving raw material records, production records, investigations/CAPA, and change control. Additional responsibilities include manufacturing floor support and continuous improvement of quality processes.

• Implementation and continuous improvement of the company’s quality systems.
• Documents authorship, review, and approval of SOPs and associated documents.
• Reviews/approves master batch records
• Raw material and product review and release.
• Oversight, review, and approval of investigations, CAPA, and change controls.
• Contributes to a culture of quality ownership, compliance, and continuous improvement
• Communicates quality-related information to internal team with guidance and recommendations.