Reporting to the Microbiology Team Coordinator, the role of the Microbiologist is to perform QC laboratory tests on in-process, intermediate and finished vaccine products. To perform in a range of additional varied work activities, including data collation and housekeeping which support the delivery of team objectives within timelines. To participate in ad hoc studies such as technical/validation studies and provide technical expertise and advice around specific tests in troubleshooting.
Responsibilities
1. To operate within the required standards of HSE (Awareness of Risk Assessments, Accidents, Incidents, Near Misses, NOSIs) and company Quality Systems and policies in accordance with Orange Guide and CFR regulations.
2. To perform accurate and reliable laboratory tests and generate results to cGMP standard by entering and authorising test data. Including the investigation of any invalid, OOS/OOT results within the GLIMS system, in accordance with current company requirements and SOPs. To consult with QA and where required initiate Veeva investigations where deviations have occurred. To ensure that the maintenance, qualification and calibration of laboratory equipment used is up to date and at the required GMP standards. To use only approved and validated assay processes and reagents. To participate in laboratory administration, including the complete and review of logbooks and PCS alarms generated progression of Change Controls, SOP reviews and closure of assigned Corrective/Preventative actions.
3. To participate in department housekeeping activities, such as cleaning, ordering and maintenance of stocks. To participate in planning and execution of ad hoc projects such as technical and validation studies. To troubleshoot in the resolution of testing problems where required.
4. To maintain responsibility for upkeep of own training records and to operate within the scope of trained activities. To provide training, coaching and mentoring for technical activities within the department in accordance with the appropriate skill block
Minimum Education Requirements
5. Educated to NVQ level 2 or equivalent in a relevant scientific discipline as a minimum requirement.
6. Computer Literate.
Minimum Experience Requirements
7. Experienced in the relevant testing discipline within the Pharmaceutical industry
8. Proven experience working in Microbiology
About CSL Seqirus
CSL Seqirus is part of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit and CSL Plasma at .
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