QC Senior Specialist, Lab Support

This is what you will do:The QC Senior Specialist, Lab Support primary focus will be supporting all day to day routine maintenance and calibration activites for QC laboratory equipment which are in a validated state in the cGMP Laboratories at AAMF. This will also require support for all associated laboratory software.This individual will be a high functioning, highly adaptable resource for the Laboratory Support Equipment team and will conduct activites in alignment with site SOPs and regulatory standards for laboratory equipment qualification and maintenance.You will be responsible for:Daily instrument supportPlanning, executing and documenting the PM/Cals on laboratory equipmnet released for use in a cGMP regulatory environmentAccompanying vendors (as requried) to ensure all documenation generated as part routine calibration/requalification is completed in a complant mannerReview and approval of PM/Cal validaton documentaiton or reportsGeneration and resolution of protocol deviations and descrepancies as requiredActing as primary contact for Lab Support for INFOR CMMSWorking closely with user groups to evaluate, develop, implement and maintain laboratory equipment and softwareMaintaining laboratory equipment in accordance with CGMPs, Part 11 and other regulatory requirementsAdministration of lab software and CDSConducting User access reviews on laboratory operting software Conducting Periodic review on laboratory operting software You will need to have:Working knowledge QC Lab systems and equipmentIn depth knowledge and understanding of current regulatory requirements for cGMP laboratory equipmentThe duties of this role are generally conducted in an lab environment. As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry 15/30 pounds unassisted/assisted; work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; gown/degown PPE; use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.We would prefer for you to have:A minimum of 5 years experience in a similar roleA degree in chemistry, software or an engineering related disciplineExcellent technical competancy in relation to instrumentation and equipment validationSkilled in organising, planning and priority setting along with strong time management skillsWorks very well in a collaborative mannerTakes a structured, analytical approach to problem solvingDate Posted27-Mar-2024Closing Date28-May-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.