LSC have a great contract opportunity for a QC Analyst to join a biopharmaceutical company in Athlone focused on serving patients with severe and ultra-rare disorders through the innovation, development and commercialization of life-transforming therapeutic products.
If you have 3+ years of experience working in the biochemistry, pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
The QC Analyst will support Chemistry and Microbiological product testing and environmental monitoring for Drug Product and Drug Substance manufacture. The QC analyst will also provide technical support with regard to facility testing oversight, test method validation and introduction of new technology to the laboratory. The QC analyst will be an SME on product testing and environmental monitoring with responsibility for investigation and report writing.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Perform analytical testing and environmental monitoring sampling and testing for all cleanroom facilities
- Ensuring high cGMP and GLP standards are maintained while testing by adapting a right first time approach
- Ensure all safety requirements within the lab are adhered to at all times and identify and escalate any safety concerns appropriately.
- Adherence to schedules and targets to meet regulatory and business requirements.
- Validation/Qualification of Microbiology and Chemistry analytical test methods and testing systems including the generation of associated reports.
- Represent QC department in internal and external audits where appropriate and close out of actions/ recommendations identified from both internal and external audits.
- Perform technical review of data generated in laboratory, validation protocols and reports and provide technical support to Manufacturing and Projects
- Actively identify and implement continuous improvement initiatives with 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 and to implement effective corrective and preventative actions while ensuring all investigations are closed with the specified lead-time.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- BSc (Hons) in biosciences (e.g. Microbiology/Chemistry etc.) and 3 years' experience in a cGMP in a QC laboratory environment and laboratory equipment associated with biopharmaceutical analysis.
- The position requires the ability to understand and follow written SOPs, to accurately and legibly record work in real time, and pay close attention to detail.
- The individual must be able to perform routine tasks with a minimum of supervision.
- The individual should have a 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
- Experience in both Chemistry (HPLC, UV) and microbiological technique
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 Jenny Murphy at LSC on 021 4777329 if you have any more questions about this role!
