
Expert Microbiologist
7 days ago
Microbiological Quality Control Specialist
">This position involves qualifying the Microbiology Quality Control lab and transferring Microbiological analytical methods. The successful candidate will be responsible for laying out the lab testing flow to ensure a streamlined process in line with lean principles.
">The full analytical scope of QC includes microbiology, mycoplasma (DNA) analytics, analytical chemistry, bioassay, raw materials, stability and in-process testing. Advanced analytical methods such as rapid ID techniques and paperless labs will allow the successful candidate to work in an innovative environment that encourages communication and ideas for the future.
">The candidate will have responsibilities in analytical transfer and qualification of methods. This role is ideal for someone who is eager to continuously learn, improve and develop.
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- 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 environmental monitoring, WFI testing, growth promotion testing, In-process product testing, Final product testing such as bioburden and endotoxin testing.">
- 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.">
- Follow up-to-date analytical practices with reference to pharmacopoeias, specifications, regulations and industry standards.">
- 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.">
- Third Level science qualification in Microbiology preferred.">
- Experience and critical skills in analytical microbiology, in a GMP setting.">
- Knowledge of cGMP.">
- Report, standards, policy writing skills required.">
- Lean Six Sigma Methodology experience."]">">
We are looking for a highly skilled professional with:
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- 1-2 years' relevant experience in Microbiological Quality Control.">
- Excellent analytical and problem-solving skills.">
- Ability to work independently and as part of a team.">
- Strong communication and interpersonal skills.">
- Familiarity with laboratory information management systems (LIMS).">
- Knowledge of cGMP and regulatory requirements.">
- Ability to prioritize tasks and manage multiple projects.">
- High level of accuracy and attention to detail.">
- Ability to work in a fast-paced environment.">
- Flexibility to adapt to changing priorities and deadlines.">
If you are a motivated and organized individual with excellent analytical skills, please apply for this exciting opportunity.
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