Quality Control Analyst

Description: Purpose of Role: To provide data through microbiological testing regimes, from which confidence in the sterility of the finished product can be founded. Provide technical support to production on microbiological / hygiene and contamination control issues.

Key Results Areas: Perform Environmental monitoring within Grade B – D clean rooms and filling machines at the appropriate frequency. Undertake testing of key components. This includes testing of in-process samples, Raw Materials and filled product by various techniques such as T.V.A.C, Bacterial Endotoxin and Sterility testing. All testing to be completed using good Aseptic technique. Results entered into the Microbiology Database and trended where necessary. Anomalous results to be communicated to the Team leader. Undertake testing of Utility services (Water for Injection, Compressed Air, Room Particle counting). Support validation work of above techniques, when required. Time lines to meet Departmental KPI's, monitoring high RFT (Right First Time) records. Bacterial Identification, Control of type cultures and in house Media QC. Media preparation and use of the autoclave. Documentation. All documentation must be completed in real time and in full. Procedural review and updates. Compile batch summary reports ready for batch release. Compile Quality department reports to solve microbiological issues. Complete Performance Qualification documentation to the required standard. Responsible for upkeep of own training records and progressing training in line with Business needs. Provide advice to the manufacturing department on microbial, hygiene and contamination control. Feedback from other departments Consistently demonstrate required behaviours (teamwork, attention to detail etc)

Areas of Impact Affecting the Job: Testing to be carried out on both intermediate and finished product to support each product batch manufactured. This will include microbiological testing and reading of Media studies completed on filling machines. Utilities are continually monitored to demonstrate compliance. All necessary testing, both directly and indirectly associated with each product batch is completed within the target time. 100% Sterility test pass rate with no false positives. Environmental monitoring to be carried out in all clean areas when in use. Laboratory testing completed in real time. Work within a team to ensure tasks are completed in a fast-paced Laboratory, as coordinated by Seniors and Team Leader. All tasks supporting Sterility Assurance of Products and Medicines.

Planning, Organising and Controlling Day to day tasks under the responsibility of the technician are to be planned and organised as directed by the Senior Microbiology Technicians or Team Leader. It is the job holder’s responsibility to report delays or uncompleted tasks directly to their seniors.

Contact with Others: Laboratory colleagues to discuss and plan the tasks to be completed. Team leader to discuss goals and performance, and to communicate any issues as they occur. Manufacturing personnel at all levels to discuss issues and to support reasonable requests for assistance in order to maintain a Microbiological Quality focus on microbiological aspects of manufacturing. Quality Assurance to discuss issues as they arise.

Decision Making Authority The job holder interprets results and raises Non-Conformance Reports as procedural policy dictates. Decisions on microbial issues within the Manufacturing areas out of weekday hours and at weekends are the job holder’s responsibilities. Need to liaise with Shift Managers or, if the query is unadvisable, refer to the Quality Assurance Department / Microbiology Team leader at the earliest opportunity.

Knowledge, Skills and Abilities: Able to communicate both orally and in the written format to personnel at all levels. Must have a thorough understanding of the need for quality which will be derived from the attention to detail. Ideally computer literate and familiar with such programs as Word, Excel etc. Organisation of required tasks, especially where priorities change Excellent communication skills within team Customer focus (internal and external), Teamwork, Initiative, Maximising performance Preferably pharmaceutical knowledge and experience A Degree qualified or HNC in Microbiology / Biological sciences + lab experience