Biocatalysts is comprised of 4 companies, headquartered in Cardiff (Wales, UK) and co-located in Buttelborn (Germany), Nieuwkuijk (Netherlands) and Tampa (Florida, USA). Brought together as an integrated Bioproducts Division in October 2023, it is a wholly owned subsidiary of BRAIN Biotech Group, based in Zwingenberg (Germany). We serve customers globally in markets such as food, baking, beverage and pharma / life science, with a view to “become and stay the world’s leading speciality enzyme company and by the quality and dedication of our people, exceed our customers’ expectations”.
To be part of the Quality function within the Compliance team, responsible for ensuring that all raw materials and final products are tested and released in compliance with our specifications and schedule
·Understand and follow quality documents and laboratory procedures to meet the requirements of quality standards and contribute to the review and writing of quality documents.
·Be conversant with and adopt the procedures stated in the Quality & Environmental Management System and its supporting documents.
·Ensure NCR actions are completed within the agreed timelines.
·Quality check formulations by the production team.
·Quality check changes to current formulations by the production team.
·Working closely with Operations and Technical teams when developing new process/technical capabilities.
·Produce reliable, accurate data and keep accurate records of laboratory work undertaken and results.
·Analyse, interpret and evaluate data and identify results requiring further investigation seeking advice of senior colleagues as appropriate
·Participate in continuous improvement activities
* Carry out enzyme assays (validation, analysis, interpretation, trouble shooting)
* Training and development of assay technicians
* Completing analysis of samples in relation to lab work requests, product and RM verification testing programme and customer complaints within timeframe on the QC schedule.
·Manage and perform stability trials of products and/or raw materials.
·Raise OOS record for out of specification results.
* Responsible for sending samples for external testing according to the schedule.
* Responsible for receiving and managing the external testing results which includes updating verification schedule, databases, attaching hard copies of paperwork to production analysis sheets and communication to internal customers.
* Raise OOS record for out of specification results.
·Generate CoA the day before dispatch
·Move CoA to the correct folder by 12 on the day of dispatch
·Generate CoA for shelf-life extension requests.
·Draft CoA for new products/new customers.
* Responsible for control of retained samples and receipt of incoming samples.
·Ensure calibration of equipment is carried out to agreed schedules and no equipment is out of calibration.
·Complete water monitoring according to schedule.
·Conduct weekly laboratory audit.