As QC Associate, you will be tasked with performing all required Analytical testing for the support of incoming goods assessment, batch release, utilities, stability monitoring and non-routine requests in accordance with GLP, GMP and Regulatory Requirements.,

Perform Analytical testing of drug products and for the purposes of batch release and stability assessment

Perform sampling of drug products for the purposes of batch release and stability testing.

Perform and report analysis of customer complaint samples, raw material samples, utility samples and non-routine samples

Enter results of testing into LIMS as required.

Identify and initiate out of specification and out of trend results, unplanned event investigations and change controls in accordance with current procedures.

Record and review QC Analytical data to ensure it is maintained in a compliant state.

Review and report test results within customer agreed lead times.

Maintain laboratory equipment in accordance with company policies

Perform Regular stock checks on all samples and reagents within the control of the QC Analytical department

Experience working in a pharmaceutical laboratory

Knowledge of GxP requirements and principles related to Quality Control laboratories

Experience or understanding of aseptic techniques

Ability to work independently according to established methods and SOPs to perform bioassay testing as required

Experience of maintaining accurate records of laboratory work in either paper or electronic formats

Basic understanding of cGMP requirements and relevant regulatory guidance for cell-based assay

Good organisational and time management skills, able to adapt to rapidly changing priorities

Communication skills -effective reporting and presentation of bioassay results to various audiences

psen is a growing and dynamic specialty-driven biopharmaceutical company focussed on innovation and specialty care.

We are a business that is experiencing exponential growth and change, therefore presenting a wide range of opportunities and challenges, particularly here at our Wrexham site

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 for 2023

The pride of working for a company that directly impacts and changes lives for the better