Location: South Yorkshire
Salary: £27,846 plus Benefits
Hours: Full Time
Job Type: Permanent
Main Job Purpose
To assist with the daily Quality Control and Quality Assurance functions as part of the Quality Unit in support of the aseptic production department.
To assist as part of the Production team in support of aseptic manufacture.
- To inspect and release all deliveries of materials arriving on site in readiness for the manufacture of aseptic products
- To collate the environmental monitoring data of the clean rooms obtained during daily/weekly manufacturing activities: To log, incubate and inspect media, and report microbiological results according to local procedures.
- Arrange for media sample dispatch when external analysis is required.
- To input microbiological data into a customised database for trending purpose and provide reports from this database as requested by Senior Managers
- Coordinate the dispatch of materials that require sterilisation.
- To perform chemical testing on in -process and final production samples in a timely manner.
- To prepare standard and reagent solutions as per approved analytical methods.
- To maintain Good Laboratory Practices and perform regular housekeeping duties.
- To order laboratory chemicals and consumables and manage laboratory stock levels.
- To assist with process, and laboratory method development during new product introduction an ongoing equipment re-qualification.
- Support for the Production team including assembly of products for manufacture, sanitisation to participate in routine Environmental Monitoring of all clean rooms as part of Quality Control.
- To ensure reports from customers relating to product quality complaints or adverse drug reactions are documented and the essential minimum information is collected and forwarded to the Regulatory Affairs Department the same day they are received.
- Act in a professional manner at all times to promote a positive image of the company.
- To deal with other duties and responsibilities which do not change the nature of the post.
Experience and Qualifications
- A Level in science
- Science degree graduate Microbiology, Chemistry, Biochemistry (Desirable)
- Minimum 1year’s laboratory experience ideally with a chemistry or microbiology bias.
- Detail focused
- Flexibility and adaptability
- Computer literacy – Excel and Word, Quality assurance and quality systems
- Ability to work under pressure
- Ability to prioritise workload