This is what you will do: The Senior Specialist, QC Operations is responsible for managing complex analytical investigations/deviations and providing support and guidance as the need arises within the Alexion Dublin QC laboratories (Microbiological/Chemistry/Biochemistry). The Senior Specialist will also provide support with method troubleshooting, Out of Trend/Specification investigations, analytical method transfer /validation and regulatory support.
Flexible schedule required as position may include weekend work and travel.
In this role, you will be: Manage complex analytical investigations/deviations providing support and guidance as required within the QC laboratoriesWhen necessary, facilitate communications regarding deviations, change control and laboratory investigationsManage and drive complex change controls and corrective actionsCompletion of project work and implementation of initiatives designed to improve the efficiency of the laboratory function/departmentAct as subject matter expert (SME) for a number of analytical chemistry, biochemistry and/or microbiology methodsProvide technical support and conduct method troubleshooting as requiredCommunicate and provide regular updates to higher level management as required, escalating risks in a timely mannerCollaborate and lead cross-functional team on complex change controls, method troubleshooting/improvement and CAPAsSupport operations within the laboratories including compilation and review of APQRs, change controls, investigation review and process improvementsLiaise with PDCS team to provide information related to analytical test procedure and analytical data, as requiredEnsure alignment of Alexion product analytical test procedures across external laboratories and Alexion laboratoriesRepresentative on change control review boards for all products to assess impact of all change controls and manage implementation activities as requiredPerform all job functions in compliance with cGMPsSupport regulatory submission, requests and responseActively participate in audit/inspection readiness and in audit/inspectionsYou will need to have: The individual in this position is expected to have an advanced understanding of the laboratory environment and be familiar with laboratory techniques associated with the analysis of biological drug productsThis position requires the individual to understand and follow written SOPs, record all work legibly and in real time; close attention to detail is necessaryThe person in this position will be able to work off their own initiativeThis position required the individual to lead cross-functional teams and complex analytical activitiesThe person in this position must have advanced organizational skills and communication skillsThe position requires the individual to work collaboratively with colleagues, peers and managersA good understanding of the concepts and systems applied to the tests and cGMP operations is expectedAuditing experience is a plusThis position may involve some travel (approximately 10%)We would prefer for you to have: B.A. / B.Sc. or equivalent in Biological Sciences, Chemistry or other biotechnical science or equivalent experience in regulated industryPreferable 5-8 years experience within a biotech pharmaceutical or biopharmaceutical manufacturing environmentProven communication skills including providing communications to higher level managementAbility to work independently as well as a member of a team in a dynamic, fast paced environmentFlexibility to travelExperienced in technical issue resolution and working on cross functional teamsExcellent organizational skillsExperience of LIMS, EQV, Empower and documentation systems would be an advantageAstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
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