Specialist, External QC

This is what you will do:

The QC Specialistis responsible forsupporting the coordination, technical and quality oversight of routine. Testing at laboratories external to Alexion where Alexion products are tested. In addition, this positionis responsible forsupporting method troubleshooting, Out of Trend/Specification investigations, APQRs, changecontrolsand CAPAs performed at these laboratories.

You will be responsible for:

• Support the co-ordination and management of laboratories external to Alexion which support the testing of Alexion products through regular communications via weekly/monthly/quarterly meetings asdeemednecessary.
• Provide routine analytical and technical support to external laboratories where Alexion products are tested.
• Supporting the onboarding of External Laboratories, including writing of QAG.
• Support complex analytical investigations providing guidance to external laboratories.
• Whennecessaryfacilitate communicationsregardingdeviations, change control and laboratories investigations between external laboratories and Alexion staff members.
• Tracking of product testing at external laboratories and liaising with Quality and Supply Chain providingaccurateupdates on status of product testing.
• Communicate and provide regular updates to higher level management asrequired, escalating risksin a timely manner.
• Support operation of the external laboratories including review of APQRs, change controls, CAPAs, investigation review and process improvements.
• Support analytical method transfer activities into Alexion and to external laboratories.
• Provide technical support and conduct method troubleshooting asrequired.
• Liaise with the Regulatory team to provide information related to analytical test procedure and analytical data from external tests laboratories asrequired.
• Write and revise SOPs, review and approve transfer protocols and reports as assigned.
• Ensure alignment of Alexion product analytical test procedures across external laboratories and Alexion laboratories.
• Representative on change control review boards for all products to assess impact of all change controls and manage implementation activities asrequired.
• Support the supply of reference materials and critical reagents to external laboratories asrequired.
• Perform all job functions in compliance withcGMPsandmaintainaccurateand legible records.
• Ensure training is current for all job functions and attend all required company training.
• Audit external laboratories ifrequiredand support inspection readiness at external laboratories.

You will need to have:

• Bachelor's degree in a relevant scientific field;
• Minimum3years of experience in QualityControl
• Understanding ofrelevant regulatory requirements (e.g., FDA, EMA) and industry standards for quality control in pharmaceuticals.
• Strong interpersonal and communication skills, with the ability to collaborate effectively with internal and external stakeholders.
• Stronganalytical and problem-solving skills, with the ability to make data-driven decisions.
• Demonstrated commitment tomaintaininga culture of quality and compliance.
• Demonstrated ability touse AI tools to support data review and trend analysis including understandingstatistingsto be able to verify AI output data
• Ability to use AI tools to support technical writing (risk assessments, LIRS, deviations) while understanding compliance boundaries

We would prefer for you to have:

• Master's or Ph.D. in a relevant scientific field.
• Experience working in a multinational environment or with global teams.
• Experience in regulatory inspections, and/or conducting or leading internal or external audits.

The duties of this role aregenerally conductedin an office environment.As is typical of an office-based role, employees must be able, with or withoutan accommodationto:use a computer; engage incommunicationsvia phone, video, and electronic messaging;engage inproblem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard businesshours.

Our 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.