Career Category Quality Job Description ADL QC Systems (Deviations), Specialist QC. Overview: This job specification outlines the general responsibilities associated with the role of Specialist QC, QC Systems (Deviations) at Amgen Dun Laoghaire. The QC Systems team provides support to the QC function for all activities within Amgen’s Quality System associated with QC Deviation Investigations, CAPA records, Testing Results Assessments (TRA) and Change Controls. The successful candidate will join the investigations team as a senior member and focus on continuous improvement, investigations and error management.Key ResponsibilitiesChampion for Investigations in Quality ControlOwns and manages investigations for QC through DQMS and author/review investigation reportsParticipates routinely in the investigation triage processEnsures investigations are kept up to date and compliant with proceduresEnsures investigations result in robust CAPA to prevent recurrenceSeeks opportunities to improve the process and management of investigationsError Management Champion, SME for error management and error reduction in QCLeads improvement initiatives such as Predict, Prevent, Improve (PPI)Strong focus on RFT and LeanKey contact for Investigation MetricsProvides coaching, support, and mentoring on investigations to the teamBuilds relationships and partners with similar roles at ADL and the network to share lessons learned and improvementsMay own Change Controls linked to investigations and CAPAsMay provide support for protocol generation linked to QC investigationsSupports audits and inspections through preparation and participationRepresents QC at site and network levels regarding investigationsWorks with minimal supervision but knows when to seek escalationCo‑ordinates investigation team workload to prioritize tasks and meet due dates, escalating as requiredKnowledge and ExperienceHold a third‑level qualification in a science‑related disciplineMinimum 6 years of experience in a Biotechnology/Pharmaceutical settingKey competencies including planning and organization, communication, teamwork, flexibility, and adaptabilityExcellent technical writing skillsProficient in root cause analysisDetailed knowledge of the QC function and operational savvyProven experience handling GMP investigations within a Quality SystemDemonstrated leadership attributes such as delivering resultsKnowledge of error‑management methodologies and experience with the Six Boxes Approach (advantageous)Salary Range67,993.20 EUR - 91,990.80 EUR
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