- The QC Microbiology Analyst role is a critically important activity, ensuring efficient and effective compliant design, construction, qualification, and operation of our client’s Drug Substance facility in Co. Dublin.
- This position will be responsible for qualifying the Microbiology Quality Control lab and the transfer of Microbiological analytical methods including but not limited to cutting edge Rapid Microbiological Methods.
- This person will be key in the layout of the lab testing flow to ensure the process is streamlined and in line with their lean principles.
- Additional development opportunities within the micro and chemistry lab will be strongly considered to recognize the tremendous value of knowledge / experience gained by the candidate during the project phases.
- To maximize the development opportunity, the candidate will be the key talent in analytical Microbiology techniques and in current Pharmacopeia methods.
- The facility will utilize the latest innovations in technology and automation.
- The candidate will work with a high performing cross functional team of talent sourced internally and from accross the biotechnology industry. Together, the team will build a Quality culture that delivers unconstrained supply, Right First Time to the patients through an inspired team.
- The candidate will be actively supported and encouraged to continue their development and knowledge build, incorporating areas to support their future development and ability to continuously improve in their current role.
- The candidate will provide support to the team and other analysts within the lab area, including training and guidance on their area of expertise.
Core Duties and Responsibilities:
- Perform supporting activities for general lab readiness, laboratory equipment qualification and method transfers.
- Perform and carry out a variety of routine microbiological analytical techniques including but not limited to environmental monitoring, WFI testing, growth promotion testing, In-process product testing, Final product testing such as bioburden and both Kinetic turbidimetric and MCS rapid endotoxin testing in compliance with GMP requirements.
- To integrate and complete all documentation on time and be familiar with LIMS.
- To train and be trained in the use of Rapid microbiology techniques including but not limited to endotoxin testing, water bioburden testing, E.M testing, absence of bioburden testing and identification testing.
- Follow up-to-date analytical practices with reference to pharmacopoeias, specifications, regulations and industry standards.
- To update SOP’s and write protocols as required.
- Support the laboratory testing schedule to achieve an efficient QC system.
- Receive and manage samples that come into the lab for stability, in-process and release testing.
- Reagent preparation, cleaning, and routine equipment maintenance.
- Maintain good housekeeping and GLP within the laboratory.
- Calibrate and maintain all designated laboratory instruments.
- Participate in risk assessments, inspections, audits, incident investigations, etc. and implement and follow-up on corrective / preventative measures.
- Ensure training is current for all job functions performed.
- Assist in training new QC Analysts on routine procedures and practices.
- Order, stock and receive laboratory supplies.
- Maintain data integrity and ensure compliance with company SOPs, specifications and cGMP regulations.
- Ensure that cGMP standards are maintained at all times.
- Delivery of area performance to meet or exceed performance or quality goals.
- Promote and participate in the implementation and maintenance of the relevant safety programmes.
- Participate and Comply with the Quality Management System requirements.
- Responsible for driving a culture of Continuous Improvement by deploying Six Sigma tools.
- This position will be on days initially but shift work will be required.
Minimum Qualifications and Experience:
- BS in Engineering, Computer Science, or other technical degree.
- Degree qualification (Science/Quality/Technical).
- Preference Lean Six Sigma
- Ability to respond to changing priorities.
- Good aseptic technique and awareness of contamination control.
- 1-3 years industry experience with significant knowledge and experience in working in a microbiology lab unit and working with contract labs.
- Experience in compendial testing for water and environmental monitoring in clean room environments.
- Working knowledge of QC Systems (Empower, LIMS, Trending systems.)
If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
14 Danville Business Park, Kilkenny, Ireland
+353 56 77 90100
Please note, we do not require agency assistance with this role.