Kenny-Whelan are sourcing a Senior Microbiologist to lead a newly accredited Micro and Sterility laboratory in Waterford
Must have prior experience with Sterility testing /cleanrooms
Contact Jenn Dinan on 0860466583 and email firstname.lastname@example.org
The post-holder will be an experienced scientist who will need to work closely with the management team in Ireland. He or she will report directly to the Site Leader. The person will have 3 years or more relevant laboratory experience and possess, at least, a higher degree in a relevant scientific discipline. They will be considered a technical expert with a thorough understanding of the portfolio and be considered exceptionally proficient in one or more analytical techniques. Ideally, the individual will have experience of Quality Management systems and some formal Line Management or supervisory experience
They will have highly developed analytical and problem-solving skills alongside excellent interpersonal skills with a confident and assertive manner, meticulous record keeping and be conscientious and reliable in their approach to work
The overall role is of day to day technical and operational support within the laboratory
- To perform analysis as required, ensuring the efficient operation of the laboratory, to ensure that schedules are met and that the quality of work meets specified standards.
- To comply with all quality control procedures to support maintenance of the Quality Management System.
- To comply with safe working practices in accordance with Company safety policies.
- To perform any other duties as may be reasonably required commensurate with grade and experience.
- Sterility testing, Bacterial Endotoxin analysis as per Pharmacopoeia, TVC and pathogen analysis, Preservative efficacy analysis.
- Environmental monitoring, trending and identifying species.
- Method Validation including inhibiting cephalosporins.
- Perform identification of microorganisms.
- Provide technical advice to clients.
- After training, any other techniques as deemed necessary by the Line Manager to assist the business in meeting timelines.
- Ensure adequate supplies of materials and consumables are available to support projects.
- Be responsible for ensuring that all analysis performed and associated tasks are performed in accordance with SBS quality policies and procedures and satisfy the requirements of cGMP or GQCLP and are in accordance with the appropriate regulatory guidelines.
- Ensure all work is documented on controlled worksheets and in accordance with standard operating procedures.
- Ensure that any out of specification result is reported to their Line Manager in a timely manner and be prepared to take part in any resulting investigations.
- Ensure that all equipment is calibrated before use and report any non-compliant equipment to their Line Manager.
- Assist with client and regulatory audits and meetings as required
Contact Jenn Dinan on 0860466583