Talent Software Services
Quality Compliance Associate
Talent Software Services, Novato, California, United States, 94949
Duties:
Support Quality Compliance processes including inspection readiness, self-inspection program, data integrity initiatives, and regulatory certification activitiesSupport or lead continuous improvement in quality systems (procedures and systems) to improve organizational effectiveness, quality assurance compliance, and regulatory and other requirements (cGMP, ICH).Adhere and follow cGMPs guidelines and procedures. Escalate non-compliance concerns to management.Interface with other client's departments (Manufacturing, Quality Control, Technical Development, Quality Assurance, etc.) and contractors as necessaryInterpret and apply 21CFR, USP, EP, JP and ICH regulatory guidelines and directivesSkills :
Prior experience in Manufacturing, Quality Control, and Quality Management System (QMS) processesExcellent written, verbal, analytical, and interpersonal skillsEducation :
BS/BA in a scientific discipline or related field and 4-6 years in a biologics manufacturing environment
Support Quality Compliance processes including inspection readiness, self-inspection program, data integrity initiatives, and regulatory certification activitiesSupport or lead continuous improvement in quality systems (procedures and systems) to improve organizational effectiveness, quality assurance compliance, and regulatory and other requirements (cGMP, ICH).Adhere and follow cGMPs guidelines and procedures. Escalate non-compliance concerns to management.Interface with other client's departments (Manufacturing, Quality Control, Technical Development, Quality Assurance, etc.) and contractors as necessaryInterpret and apply 21CFR, USP, EP, JP and ICH regulatory guidelines and directivesSkills :
Prior experience in Manufacturing, Quality Control, and Quality Management System (QMS) processesExcellent written, verbal, analytical, and interpersonal skillsEducation :
BS/BA in a scientific discipline or related field and 4-6 years in a biologics manufacturing environment