QC Microbiologist 2
Ipsen
- Wrexham
- Permanent
- Full-time
- Perform environmental Monitoring of NDP Clean Rooms and controlled environments in accordance with current testing schedules and manufacturing activities in addition to supporting other facilities.
- Perform microbiological testing of raw materials, in-process and final product for microbial contamination within required time frames for the NDP facility and provide support as directed for other facilities.
- Identify and initiate out of specification and out of trend results, unplanned event investigations and change controls in accordance with current procedures in support of the NDP facility.
- Provide training in all key microbiological methodologies.
- Initiate and drive microbiological investigations through to completion.
- Represent QC on the NDP project teams and in meetings and provide microbiological expertise.
- Be proficient in reviewing lab methods against current pharmacopoeia and licence requirements to ensure ongoing compliance.
- Lead QC related projects e.g. process improvements.
- Responsible for completion of batch data and all associated OOS/OOT and UE records for designated batches.
- Support real time process walks within the NDP manufacturing area in accordance with site procedure.
- Qualified to degree level or equivalent in a Biological Science subject, preference towards Microbiology
- Previous experience working in a pharmaceutical microbiological laboratory
- Knowledge of aseptic techniques, US/EU cGMP's
- Excellent team player
- Flexible and agile to meet the evolving requirements of the customer/business
- Appreciation and interest in process improvement and efficiencies
- Genuine passion for Quality and understands the impact and importance within a pharmaceutical environment
- We are a business that is experiencing exponential growth and change, therefore presenting a wide range of opportunities and challenges
- Major £multi-million investment in a New Drug Product Facility to increase the scale and capability of our Wrexham site, ultimately enhancing the products we develop for our customers
- A fantastic culture and working environment with many long-serving employees
- Huge commitment to Diversity & Inclusion - almost 50% of our top 160 leaders are women
- A genuine focus on the environment and sustainability – our Wrexham site is powered by 100% renewable electricity
- Competitive salaries and enhanced benefits package which includes annual bonus, generous pension scheme, wellness allowance and so much more.
- Awarded ‘Best Workplaces’ and ‘Best Workplaces for Wellbeing’ status in the Large Organisations category, as well as ‘Best Workplaces for Women’ in 2023.
- The pride of working for a company that directly impacts and changes lives for the better