AstraZeneca
biopharmaceutical
SeniorTechnicalSupportSpecialist-QualityControl
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“Senior Technical Support Specialist - Quality Control at AstraZeneca. Skills: Empower expertise, laboratory instrument validation, instrument troubleshooting, technical writing, QC laboratory background. Lead lab equipment validation and decommissioning projects end-to-end. Troubleshoot and resolve complex instrument issues”
Industry & Context.
instrument troubleshooting; resolve complex instrument issues; root-cause investigations; issue triage
2 year Max Term contract role, based on site in North Ryde, Monday to Friday, Standard work hours with minimal need for out-of-hours calls
What They're Looking For.
Must Have
Empower expertise in a QC laboratory environment, Demonstrated validation experience for laboratory instruments or systems, Instrument troubleshooting capability, Proven deep technical writing skills across protocols, reports, deviations/OOS, and SOPs to GMP/GLP standards, Hands-on QC laboratory background, with working knowledge of analytical techniques (e.g., HPLC)
Nice to Have
Change control ownership and experience managing lifecycle changes for lab equipment/software, Data Integrity (ALCOA+) risk assessments and controls for computerised systems, admin/configuration exposure as well as user-level processing
What You'll Do.
Lead lab equipment validation and decommissioning projects end-to-end
Troubleshoot and resolve complex instrument issues
Administer and support Empower software for QC users
Own technical documentation – author
review and maintain protocols
Coordinate vendor calibrations and servicing
Champion continuous improvement and data integrity
How You'll Work.
Team & Collaboration
collaborating with vendors; coaching colleagues; sharing SME knowledge; inclusive culture that champions diversity and collaboration; welcoming, highly supportive and diverse team that values knowledge sharing and continuous improvement
Communication Scope
technical writing skills
Process & Methodology
Lead lab equipment validation and decommissioning projects end-to-end, delivering on time with robust documentation
Full Job Description
Do you have experience in lab equipment validation, and you enjoy instrument troubleshooting and technical support? Are you ready to apply your skills to support QC activities for manufacture of high-quality medicines that make a difference to the lives of patients all around the world? Then AstraZeneca might be the one for you! **About AstraZeneca** AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in four therapy areas – Oncology, Cardiovascular, Renal and Metabolism (CVRM), Respiratory & Immunology (R&I), and Rare Disease. At AstraZeneca Australia, we have been working to deliver the best value to patients for more than 60 years, and we push the boundaries of science to deliver life-changing medicines. Our manufacturing plant based in North Ryde, Sydney, is a world-class facility with a proven track record of delivering outstanding supply performance and is regarded as one of the most cost-efficient and successful manufacturing sites in the AstraZeneca global network. **What you’ll do:** As part of our Quality Control Technical Support team, you’ll be one of the laboratory’s go-to specialists for instrumentation and Empower administration. _This is a full time 2 year Max Term contract role based on site in North Ryde Monday to Friday._ **Key responsibilities:** * Lead lab equipment validation and decommissioning projects end-to-end, delivering on time with robust documentation and GMP/GLP compliance. * Troubleshoot and resolve complex instrument issues across HPLC and other QC platforms, minimising downtime and guiding root-cause investigations. * Administer and support Empower software for QC users, including access management, data processing support and issue triage. * Own technical documentation – author, review and maintain protocols, reports and SOPs with precision; support audits, deviations and OOS management. *
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