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* Maintain laboratory and office areas in compliance with EHS and cGMP requirements. Archive completed laboratory documentation in a timely manner.
* Chemical and/or microbial based analyses of purchased and manufactured materials, utilities/EM, stability samples and non-routine samples.
* Report and approve results using standard laboratory systems ensuring all statistical monitoring charts (paper and electronic) are updated in a timely manner.
* Perform all aspects of sample handling, sample receipt, storage and disposal as per procedures.
* If authorised, perform second person verification of analytical data generated in QCL as per procedures.
* Liaise with Supervision and planners to prioritise workload to ensure lead times and expected customer service levels are met.
* Conduct the equipment calibrations, maintenance and IQ/OQ that you are trained to perform.
* Train other QCL staff in these tasks as appropriate. Write, update and review analytical workbooks, methods and procedures.
* Perform analyses and document results to support method verifications, validations and transfers.
* Assist the QCL Scientist/Equipment group when required, by participating in analytical investigations, investigative testing and method/equipment fault finding and troubleshooting.
* Follow lab purchasing procedures to ensure laboratory remains sufficiently stocked with standards/reagents and consumables.
* If trained and authorised to do so, purchase standards/reagents/consumables. Communicate with regulatory auditors such as VMD, MHRA, FDA etc in accordance with company policy.
What You Need to Succeed (minimum qualifications):
* Science Degree or Relevant Experience.
* Expertise in Compendial testing (, USP, JP etc)
* Experience in FTIR, NIR, Spectrophotometry and classical wet chemistry techniques
* Experience with HPLC/GC would be an advantage but not essential
* Able to work with minimal supervision and experience of a GMP environment
Don’t meet every single requirement?Studies have shown underrepresented groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!
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