LSC have a great contract opportunity for a QC Micro Analyst to join a Cork based Biopharmaceutical company. The site manufactures low volume bulk API for Phase III clinical trials, initial product launch and long term market support. The team on site grow, purify, formulate and bulk fill mammalian cell culture derived APIs for medicines intended for human use.
If you have a B.S. in a scientific discipline and ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
* Microbiological method verification and B&F testing in the sterility test suite.
* Support for sterility testing including EM, utilities testing, BI, growth promotion, ID's.
* Perform primary review of QC raw data and trend results
* Prepare protocols, summaries, and reports-often for direct submission to pharmaceutical regulatory agencies
* Draft QC SOPs
* Act as technical resource (SME)and train other analysts in areas of expertise
* Evaluate results against defined acceptance criteria
ABOUT YOU - ARE YOUR SKILLS A MATCH?
* B.S. in a scientific discipline with 3+ years of relevant laboratory experience in sterility assurance testing.
* Ability to work independently and meeting established timelines.
* Knowledge of cGMPs.
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Apply via this advert or contact Alison Jones at LSC on 021-4777329 if you have any more questions about this great opportunity!