Contract - Quality Assurance Specialist

Vedanta Biosciences is a biopharmaceutical company developing treatments for gastrointestinal diseases, specifically orally administered therapy for recurrent C. difficile infection. They are seeking a Contract - Quality Assurance Specialist to support QA operations, document control, audits, and compliance with GMP regulations. The company utilizes a sophisticated industry-leading product engine and maintains extensive clinical data.

Requirements

• Ensure Vedanta facilities, utilities, manufacturing, and testing procedures and processes are compliant with GMP and phase-appropriate to support production and distribution.
• Support QA operations in manufacturing activities including but not limited to on floor support, executed document review, disposition and release (internal and external CMO), walkthroughs, etc.
• QA Document/Training in document control activities including document upload to QMS system and archiving of records for both document and training.
• Owning the revision of records and SOPS to align with GMP requirements as assigned.
• Collaborating with organization on the training of, and guidance/support of QMS system records such as Deviations, CAPAs, and Change Controls.
• Leading, supporting, or implementing improvement initiatives for QA and other organizations.
• Department Functions: Continues to improve or develop Quality Assurance department processes/guidance for internal interactions or between Vedanta and external stakeholders. Maintain documentation in accessible format, ensure new documents are created and stakeholders notified/trained as assigned.