The QC Microbiologist is responsible for the performance of laboratory operations, to include raw material, utility, in-process and product testing by microbiological methods and environmental monitoring analysis.
Reporting to the Senior QC Microbiologist.
- Performance and reporting of microbiology testing on all raw materials, intermediates and finished products following customer, company and regulatory/industry requirements
- TOC, pH, conductivity
- Performance of routine tasks and other none routine activities required in support of quality control laboratory functions.
- Ensure all testing performed is reported within the most efficient timeframe.
- Laboratory maintenance- housekeeping, self-inspections and stock control – support the re-order systems and communication with key suppliers.
- Support the environmental monitoring and product testing requirements for bulk product manufacturing, including collection and processing of environmental monitoring samples and data analysis
- Data trending and performance of quality investigations
- Documentation of laboratory results in accordance with cGMP and company procedures.
- Ensure training status compliant with matrix requirements and to assist in training of laboratory and production staff.
- Maintain and improve knowledge of microbiological techniques
- Contribute to team building, training and problem-solving initiatives internally and cross site.
- Liaise with functional groups both within and outside QC as appropriate to ensure projects and plans are progressed
- Preparation and execution of laboratory protocols and reports, as assigned.
- Qualification of media, microbial techniques and relevant equipment.
- Ensure that all laboratory activities are in compliance with all Health & Safety Guidelines, with particular reference to COSHH and Biological Safety Regulations and Health & Safety at Work Act 1974.
Skills & Qualifications:
- HND or equivalent qualification in a relevant biological / microbiological subject area.
- At least 2 years’ experience in a microbiology testing laboratory and experience of working in a regulated environment, pharmaceutical or medical laboratory in a related role to cGMP or within alternative quality system (UKAS/ISO 9001) such as Contract testing laboratory.
- Essential technical knowledge in microbiology and microbiological techniques
- Good understanding and application of cGMP and regulatory requirements including USP, PhEur, Orange guide and Current ICH guidelines applicable to the role.
- Excellent communication / interpersonal and organisational skills, demonstrating attention to detail.
- Be able to work in a team and individually.
- Proficient in the use of computers and using Microsoft Office package.