QC Laboratory Supervisor

Location

Newbury, Berkshire | United Kingdom

Job description

We are a leading biotechnology company specializing in the development and manufacturing of innovative biological products. Seeking a dedicated and detail-oriented QC Laboratory Supervisor to join our dynamic team in Newbury. Our state-of-the-art laboratory facility is equipped with cutting-edge technologies and serves as the hub for our research and development activities. We are committed to making a positive impact on health and the environment through our scientific advancements.

The Role

• Supervising the Quality Control team.

o Ensuring day-to-day running of QC Microbiology laboratory

o Line management responsibility for QC Analysts including training, leadership and recruitment using People Cloud a bespoke HR toolkit.

o Training new members of staff in microbiology-related activities and ensuring that the required initial and continuing training of Lab personnel is carried out and adapted according to their needs and areas of interest.

• Delivering workflow to support the production schedules to meet customer requirement dates through:

o Execution of sampling & protocols required as part of sterile process assurance.

o Performing routine QC testing to support batch release, validation, and method development studies.

o Performing in-house batch release testing on vaccines (including weekend cover) and managing microbiological testing for environmental monitoring and other duties to support the GMP facility.

o Overseeing the lab's input for the daily PDR (Plan, Do, Review) Meeting.

• Maintaining Quality standards through:

o Continuous improvement of the sterile process assurance.

o Presenting technical microbiological issues and results to internal and external audits

o Ensuring the QC lab performs testing and release of Raw Materials, packaging materials, intermediate, bulk and finished products.

o Keeping procedural documents (SOPs) and policies on Environmental Monitoring relevant and up to date with regulation guidelines.

o Responsible for microbiological test implementation: method development, validation, and documentation.

o Ensure that the monitoring procedures are performed on time for the trending of microbiological data for all required sampling, ensuring data integrity.

o Investigations of out of specifications/ atypical results obtained from microbiological

testing.

o Lead microbiology compliance in QC related tasks

o Documenting microbiological records to ensure compliance with cGMP.

o Regularly reporting of results and summaries of own work to line manager.

• Ensure compliance with required Health and Safety standards and ensure that there is a representative of the Lab on the Health and Safety committee.
• Contribute to the development of the Company's operational process by:

o Maintaining effective working relationships within and between all team members.

o Providing laboratory KPI information, assisting your line manager in reporting performance.

o Responsible for ensuring the maintenance, qualification, and validation of microbiology laboratory equipment and supporting new equipment installation as required.

Experience Required

• A BSc/MSc Degree or equivalent in a relevant field
• Good experience of working in microbiology, specifically supporting sterility testing and environmental monitoring activities in pharmaceutical environment
• Good understanding of GMP and ability to front external audits.
• Good Microsoft Office skills
• Excellent Communication, leadership and Team working skills.
• Excellent accuracy and attention to detail.
• Experience in QC chemistry would be advantageous but not essential.
• The ability to manage multiple projects and tasks in an evolving environment.
• Technical knowledge of emergency (bespoke} vaccine products.

Job tags

Salary