QC Microbiology Supervisor

Position Summary

The QC Microbiology Supervisor will support the QC Microbiology department with emphasis on environmental and facilities monitoring, microbiological testing such as Endotoxin and Sterility, technical support with regard to method validation, regulatory updates and new technology.

The QC Microbiology Supervisor will supervise a team of analysts.

Principal Responsibilities

The successful candidate will be responsible for:

• Ensuring high cGMP, GLP standards are maintained while testing and adherence to schedules and targets to meet regulatory and business requirements.
• Supervise a team of micro laboratory analysts.
• Validation/Qualification of Microbiology test methods and test systems such as the Endotoxin test system, Sterility Test Isolator and Identification system.
• Collaborate with the QC System Specialist to develop and implement LIMS for the Microbiology Laboratory.
• Lead and participate Quality Risk Assessments relating to the Microbiology.
• Maintain regulatory compliance through the creation and maintenance of programs for laboratory testing, training, SOPs and validation. Preparation of documentation for audits carried out by internal auditors and Regulatory bodies.
• Represent the Microbiology department in internal and external audits where appropriate.
• Close out of actions/ recommendations identified from both internal and external audits.
• Assist in ensuring that current compliance issues and trends, both internal and site-wide, are critically evaluated and training is provided where appropriate.
• To maintain competence and keep up to date with all new technologies, procedures and methods used in the Microbiology Laboratory.
• Perform technical review of data generated in laboratory, validation protocols and reports.
• To represent the Microbiology laboratory at internal and external meetings in the absence of the Laboratory Manager.
• To keep management updated on issues arising within the laboratory.
• To report to and be directed by the Laboratory Management and to organize and schedule the smooth running of the laboratory in the absence of the Laboratory Manager.
• Provision of trouble shooting and similar expertise in the resolution of laboratory issues as they arise from time to time utilizing Root Cause analysis tools
• To ensure a high standard of housekeeping is maintained in the Laboratory.
• Completion of project work and implementation of initiatives designed to improve the efficiency of the laboratory function/department.
• To travel and represent the organization as may be required for technical knowledge and ability.
• To ensure all instruments/equipment are maintained in a calibrated and operational state.
• Provide Technical support to Manufacturing and Projects which the company undertakes through project participation, investigation, validation and testing activities and prepare Technical Reports as required.
• Scheduling of testing, review and authorization of microbial data.
• Investigate out of specification/limit results utilizing Structured Problem Solving, Root Cause Analysis tools in conjunction with the Microbiology Associate Director, QA and other relevant departments and to implement effective corrective and preventative actions while ensuring all investigations are closed with the specified lead-time on TrackWise.
• To train laboratory personnel and play appropriate role in the development, operation and evaluation of training/re-training programs

Qualifications

• Minimum of 4 years of experience in cGMP Quality environment.
• Experience in environmental and facilities monitoring, testing of sterile drug product, raw materials, and aseptic filling process of sterile pharmaceutical /biopharmaceutical products.
• Good knowledge of current regulatory requirements for Microbiology / Sterility Assurance in support of cGMP operations supporting clinical and commercial manufacturing.
• Subject Matter Expert in Method Validation, Endotoxin testing
• Experience in Sterility and Identification testing desirable
• Experience in Quality Risk Management.
• Excellent knowledge of LIMS and experience in the setting up and implementation of LIMS for Microbiology.

Education

• Degree in Microbiology or related science.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.