QC Analyst at AstraZeneca

Athlone, Leinster, Ireland -

Full Time

Start Date

Immediate

Expiry Date

13 Feb, 26

Salary

0.0

Posted On

15 Nov, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Analytical Testing, Environmental Monitoring, cGMP, GLP, Microbiology, Chemistry, Technical Writing, Report Writing, Problem Solving, Root Cause Analysis, Laboratory Equipment, SOPs, Continuous Improvement, Safety Standards, gLIMs, HPLC, UV

Industry

Pharmaceutical Manufacturing

Description

Are you ready to dive into the world of Chemistry and Microbiological product testing? As a QC Analyst at Alexion Athlone, you'll play a pivotal role in ensuring the quality and safety of Drug Product and Drug Substance manufacture. You'll be at the forefront of environmental monitoring, providing technical support for facility testing oversight, test method validation, and introducing new technology to the laboratory. Become an expert in product testing and environmental monitoring, with the responsibility for investigation and report writing. Are you up for the challenge? Accountabilities: • Perform analytical testing and environmental monitoring sampling and testing for all cleanroom facilities. • Ensure high cGMP and GLP standards are maintained while testing by adapting a right first time approach. • Adhere to all safety requirements within the lab at all times and identify and escalate any safety concerns appropriately. • Meet regulatory and business requirements by adhering to schedules and targets. • Validate/Qualify Microbiology and Chemistry analytical test methods and testing systems, including generating associated reports. • Represent the QC department in internal and external audits where appropriate and close out actions/recommendations identified from both internal and external audits. • Perform technical review of data generated in laboratory, validation protocols, and reports, providing technical support to Manufacturing and Projects. • Actively identify and implement continuous improvement initiatives within the QC lab. • Investigate out-of-specification/limit results utilizing Structured Problem Solving, Root Cause Analysis tools in conjunction with the Laboratory Supervisor, QA, and other relevant departments, implementing effective corrective and preventative actions while ensuring all investigations are closed within the specified lead-time. • Order, stock, and receive laboratory supplies. • Provide lab support including reagent preparation, cleaning, and routine equipment maintenance. • Ensure training is current for all job functions performed. • Support training of other analysts within the QC lab. • Receive and manage samples that come into the lab for testing to ensure that all samples are tested appropriately in a timely manner, including review/authorization. • Perform QC support activities such as sample shipments, CoA review, batch pack review, and material release as appropriate. • Prepare and present monthly and quarterly Environmental Monitoring trends. • Prepare annual Environmental Monitoring reports. • Coordinate and track all alert/action excursions for the QC team. Essential Skills/Experience: • BSc (Hons) in biosciences (e.g., Microbiology/Chemistry etc.) and 3 years’ experience. • Working knowledge of cGMP in a QC laboratory environment and laboratory equipment associated with biopharmaceutical analysis. • Ability to understand and follow written SOPs, accurately and legibly record work in real time, paying close attention to detail. • Ability to perform routine tasks with a minimum of supervision. • Strong understanding of lab safety and demonstrated ability to recognize and mitigate safety risks. • Strong technical writing and report writing skills. • Experienced in the use of gLIMs. Desirable Skills/Experience: • Experience in both Chemistry (HPLC, UV) and microbiological techniques. At AstraZeneca, we are driven by a passion for innovation that transforms lives. Our commitment to rare disease biopharma places us at the cutting edge of biomedical science. With a global reach and potent capabilities, we are uniquely positioned to address unmet needs in rare diseases. Our culture fosters connections that inspire new ideas, empowering you to grow alongside exceptional leaders. Here, your career is not just a path but a journey to making a difference where it truly counts. Ready to make an impact? Join us at AstraZeneca! Date Posted 14-Nov-2025 Closing Date 27-Nov-2025 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.

Responsibilities

As a QC Analyst, you will perform analytical testing and environmental monitoring to ensure the quality and safety of drug products. You will also be responsible for investigation and report writing, as well as providing technical support for facility testing oversight.