Deviations Investigation Specialist

Our Work MattersAt Kindeva we make products that save lives ensuring better health and well-being for patients around the Impact You Will MakeThe Deviations Investigation Specialist partners with Operations Quality and cross-functional teams to investigate manufacturing and quality events determine root cause assess risk and support the development of effective corrective and preventive actions. This role leads and facilitates deviation investigations authors investigation records and risk assessments and ensures investigations are completed accurately objectively and in compliance with applicable GMP and quality system Deviations Investigation Specialist serves as a key resource in identifying systemic issues improving compliance and driving sustainable solutions that enhance product quality and manufacturing ResponsibilitiesLead deviation investigations related to manufacturing and operational events ensuring timely completion and compliance with site quality systems and GMP with Operations Quality Engineering Validation and other stakeholders to gather facts assess impact establish containment actions and determine appropriate response plans. Facilitate root cause investigations using structured problem-solving methodologies and data-driven analysis to identify the most probable causes of events. Perform and document risk assessments to evaluate product quality regulatory operational and business impacts. Author clear thorough and technically sound investigation reports ensuring conclusions are supported by facts evidence and data. Develop and support corrective and preventive actions (CAPAs) that appropriately address root causes and reduce recurrence. Author or support quality system documentation including deviations CAPAs risk assessments change controls effectiveness checks and related records as required. Analyze investigation data and trends to identify recurring issues and opportunities for continuous improvement. Support training coaching and collaboration efforts to improve investigation quality problem-solving capabilities and compliance across the QualificationsBachelors degree in Engineering Chemistry Biology Pharmaceutical Sciences Quality Business or a related discipline; or equivalent combination of education and experience. 3 years of experience in a GMP-regulated manufacturing environment. Experience authoring investigating reviewing or approving deviations investigations or other quality system records. Experience with quality management systems and regulated documentation practices. Experience utilizing root cause analysis and structured problem-solving methodologies. Strong technical writing analytical and communication skills. Ability to effectively collaborate with cross-functional teams and influence QualificationsExperience in pharmaceutical biotechnology medical device or other regulated manufacturing environments. Experience supporting aseptic processing sterile fill-finish visual inspection packaging or device manufacturing operations. Experience authoring or supporting risk assessments CAPAs change controls and effectiveness checks. Experience participating in regulatory inspections customer audits or internal audits. Lean Six Sigma Green Belt Black Belt ASQ certification or similar quality-related credential. Experience within a CDMO environment.