TalentBurst
Quality Compliance Associate
TalentBurst, Novato, California, United States, 94949
Quality Compliance AssociateNovato, CA, 9494906 Months
Description
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 proceduresEscalate non-compliance concerns to management.Interface with other client departments (Manufacturing, Quality Control, Technical Development, Quality Assurance, etc.) and contractors as necessaryInterpret and apply 21CFR, USP, EP, JP and ICH regulatory guidelines and directivesOther duties as assignedSkills:
Prior experience in Manufacturing, Quality Control, and Quality Management System (QMS) processesExcellent written, verbal, analytical, and interpersonal skills.Education:
BS/BA in a scientific discipline or related field and 4-6 years in a biologics manufacturing environment.
#TB_PH
Description
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 proceduresEscalate non-compliance concerns to management.Interface with other client departments (Manufacturing, Quality Control, Technical Development, Quality Assurance, etc.) and contractors as necessaryInterpret and apply 21CFR, USP, EP, JP and ICH regulatory guidelines and directivesOther duties as assignedSkills:
Prior experience in Manufacturing, Quality Control, and Quality Management System (QMS) processesExcellent written, verbal, analytical, and interpersonal skills.Education:
BS/BA in a scientific discipline or related field and 4-6 years in a biologics manufacturing environment.
#TB_PH