
Bioanalytical Microbiologist Position
2 weeks ago
Job Description:
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- This role is crucial in ensuring the efficient and effective operation of the new strategic Biotech Drug Substance facility.">
- The successful candidate will be responsible for qualifying the Microbiology Quality Control lab and transferring Microbiological analytical methods, including Rapid Microbiological Methods.">
- They will also play a key role in laying out the lab testing flow to ensure streamlined processes in line with lean principles.">
- In addition, this person will have opportunities for further development within the micro and chemistry labs.">
Responsibilities:
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- To perform supporting activities for general lab readiness, laboratory equipment qualification, and method transfers.">
- To perform and carry out routine microbiological analytical techniques, such as environmental monitoring, WFI testing, growth promotion testing, in-process product testing, and final product testing.">
- To integrate and complete all documentation on time and be familiar with Laboratory Information Management Systems (LIMS).">
- To train and be trained in the use of Rapid Microbiology Techniques.">
- To update SOPs and write protocols as required.">
- To support the laboratory testing schedule to achieve an efficient QC system.">
- To receive and manage samples coming into the lab for stability, in-process, and release testing.">
- To prepare reagents, clean equipment, and maintain routine equipment maintenance.">
- To maintain good housekeeping and Good Laboratory Practice (GLP) within the laboratory.">
- To calibrate and maintain designated laboratory instruments.">
- To participate in risk assessments, inspections, audits, incident investigations, and implement corrective/preventative measures.">
- To ensure training is current for all job functions performed.">
- To assist in training new QC Analysts on routine procedures and practices.">
- To order, stock, and receive laboratory supplies.">
- To maintain data integrity and ensure compliance with company SOPs, specifications, and cGMP regulations.">
- To promote and participate in the implementation and maintenance of relevant safety programs.">
- To participate and comply with Quality Management System requirements.">
- To drive a culture of Continuous Improvement by deploying Six Sigma tools.">
Requirements:
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- A minimum of 1-2 years' experience in a relevant field.">
- Experience and critical skills in analytical microbiology, preferably in a GMP setting.">
- Knowledge of cGMP.">
- Report, standards, policy writing skills are required.">
- Lean Six Sigma Methodology experience is desirable.">
- Effective communication, presentation, and interpersonal skills are essential.">
- A Third-Level science qualification, preferably in Microbiology.">
Benefits:
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- This is a unique opportunity to work with a high-performing cross-functional team sourced from across the biotechnology industry.">
- The candidate will be actively supported and encouraged to continue their development and knowledge build.">
- The position offers a chance to work in a state-of-the-art facility utilizing the latest innovations in technology and automation.">
- The successful candidate will be part of a quality-driven organization striving for unconstrained supply and Right First Time delivery to patients.">
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