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Temporary QC Analyst (Product)

Deeside, Flintshire, CH5 2UA

To support our growth, we are recruiting a QC Analyst who has the knowledge, experience and passion to help provide a world class analytical testing service. Reporting to the QC Team Leader, you will be responsible for the performance of laboratory operations, to include the testing, in-process and product release samples using analytical methods.

ADC BIO is an innovative biotechnology Company developing new process technology to speed, simplify and significantly lower the production costs of the latest generation of anti-cancer blockbuster drugs, Antibody Drug Conjugated (ADCs). Formed in 2010, ADC BIO have recently secured significant investment that is enabling a new dedicated 6500m2 facility in Deeside to support the rapid expansion plans of the Company.
To support this growth, we are recruiting a QC Analyst who has the knowledge, experience and passion to help provide a world class analytical testing service.
Reporting to the QC Team Leader, you will be responsible for the performance of laboratory operations, to include the testing, in-process and product release samples using analytical methods.
The candidate must have a demonstrable experience in the use of a variety of analytical methods, A self-motivational attitude and the ability and aptitude to learn new skills within a fast-paced environment.
The key responsibilities will include:
• Performance and reporting of Analytical testing on intermediates and finished products following customer, company and regulatory/industry requirements (to include)
– HPLC (SEC, HIC, PLRP) of Proteins.
– UV – vis spectrophotometry.
– pH, conductivity, osmolality
– Capillary Electrophoresis, Iso-electric focussing, SDS PAGE
– Immuno-assays, ELISA.
• Ensure that analytical results are reported within the most efficient timeframe.
• Working with technical specialists to qualify equipment and Analytical Methods to ICH requirements
• Performance of routine tasks and other none routine activities required in support of quality control laboratory functions.
• Laboratory maintenance- housekeeping, self-inspections and stock control – support the re-ordering systems and communication with key suppliers.
• Data trending and assisting in the performance of quality investigations
• Documentation of laboratory results in accordance with cGMP and company procedures.
• Ensure training status compliant with matrix requirements and to assist in training of laboratory and production staff.
• Maintain and improve knowledge of analytical techniques
• Contribute to team building, training and problem-solving initiatives internally and cross site.
• Preparation and execution of laboratory protocols and reports, as assigned.
• Qualification of critical reagents, reference materials and standards
• Ensure that all laboratory activities are in compliance with all Health & Safety Guidelines, with particular reference to COSHH and Biological Safety Regulations and Health & Safety at Work Act 1974.
Skills & Qualifications Required:
• >2 years’ experience working in an analytical testing laboratory and experience of working in a regulated environment, pharmaceutical , Contract testing laboratory or medical laboratory in a related role to cGMP is essential
• Technical knowledge and experience in Protein analysis including techniques such as HPLC, UV, CE, IEF, ELISA, SDS PAGE
• Understanding of cGMP and regulatory requirements including USP, PhEur, Orange guide and Current ICH guidelines applicable to the role.
• Excellent communication / interpersonal and organisational skills, demonstrating attention to detail.
• Be able to work in a team and individually.
• Proficient in the use of computers and using Microsoft Office packages.
ADCBio offer a generous benefits package including a competitive salary p.a. (negotiable depending on experience and qualifications) plus 25 days holiday + statutory (+ death in service and private medical cover following a qualifying period).
Please apply by emailing a CV with a covering letter detailing your current remuneration package.
**NO CALLS FROM AGENCIES WILL BE TAKEN IN RELATION TO THIS VACANCY**

Apply Now.