Associate Quality Assurance Specialist: Drug Product
CurrentEssential Duties and Responsibilities:- Work on and lead efforts to establish new programs including start-up of formulation, filling,inspection, assembly, and assist the pack and label team.- Perform assessments of existing procedures/documents to gauge appropriateness for the inclusion ofdrug product operations; where current documents are not adequate, identify path forward forestablishment of new procedures.- Develop, write, review, and approve SOPs, specifications, and other documents. This includesdocuments for operation and facility SOPs, quality training, batch documentation, etc.- Accountable for maintaining project timelines to support the evolving business.- Perform On-The-Floor quality review of documents, such as: equipment logs, training records, testingresults, batch records and supporting documents.- Review and approval of documents (electronic and paper-based)- Perform daily on-the-floor duties to ensure facilities, equipment, materials and documentation complywith SOPs and safety standards.- Provide mentorship during on-the-floor manufacturing- Support audits, inspections and investigations- Perform quarantine, segregation of material and line clearances
